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TOPIC: Refractive Lens Exchange (RLE)

Oculentis faulty lenses! 30 Dec 2018 18:54 #11

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(These posts will seem out of order because of image upload limit; please read backwards :)

Reading example:



Street vision shows up some very annoying artefacts too. This is bright ambient light but note the double image and variable sharpness of edges:



Watching TV is not fun; this is about three metres away:



Driving at night will be on the next post.
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Oculentis faulty lenses! 30 Dec 2018 18:49 #12

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@IncyB Of course, it might even be worse than you think (it usually is). Whilst trawling the inter webs for information on light transmission in Oculentis M Plus MF IOLs I came across this, from Eye News website originally published (print I assume) in October / November 2014:

Injectable IOLs for macular pathologies

The Lentis Mplus High Add is an injectable IOL for patients with macular pathologies, first introduced by Oculentis in late 2013. It will now enter into a phase of controlled trials limited to three centres in Germany, designed to determine the inclusion criteria and the residual dependence on low vision aids for these patient groups. The early feasibility studies evaluating the Mplus High Add IOL carried out by the University of Heidelberg show considerable potential for improving quality of life for patients with age-related macular degeneration (AMD). This aspheric multifocal IOL has an 8.0D near addition, with 1.5 times magnifying power. According to Professor Auffarth, the Mplus High Add IOL is most suited to patients with stable macular disorders who have a minimum visual acuity of 1.0 logMAR and a maximum estimated visual acuity of 0.5 logMAR.

www.eyenews.uk.com/features/ophthalmolog...k-into-the-iol-space

I read this in conjunction with a video Sasha sent me on another subject, but which contained one very pertinent slide, making a comparison between outcomes of MF IOL exchanges in patients with cataracts in their late seventies to mid eighties, with outcomes of people with the same lenses much earlier in life (and without significant cataracts). All that neuroadaptation stuff to one side, this particular slide was only complaining about light transmission values in the 85% range, whereas my understanding of M Plus is that distance vision has LTV of a truly atrocious 60%. And that's not faulty, that's how the damned thing was designed.

So my take on Oculentis is that even before you get to lens opacification - which is a major worry for the industry - these lenses were only ever designed to be implanted in people whose starting vision was sufficiently bad that ANY lens implant would represent an improvement in clarity. The trouble is that companies like Optical Express have been putting these lenses in to patients where lens replacement is an entirely inappropriate intervention. So the fact they have a great many profoundly unhappy patients currently suing them should hardly comes as a surprise. Anyway;

I had Lentis M Plus lenses implanted in Jan 2013, and from day one my vision has been atrocious. What's rather more troubling is that it seems to be getting worse quite rapidly. When I mentioned this in passing to the delightful Mr Stephen Hannan at Optical Express I received, by courier, a letter basically telling me to never darken their doorways again. In fairness I hadn't expected anything else, but it did emphasise quite how disingenuous OEs approach to patient care is. Anyway again;

It also struck me a while back that in all of the literature I have read concerning patient outcomes of MF IOL implants nobody had really tried to represent the patient experience in visual terms. I mean, in fairness it's tricky, right? Well, no. I've been using Photoshop since version 1 and if the police can use it for photofits then some multi-billion dollar turnover optics company like Zeiss or Oculentis should have damn well tried it. But they haven't, so I have.

The following seven images are based on photos taken on an iPad pro and then retouched in-situ to match as closely as I can the viewing experience of a patient with Oculentis M Plus multifocal intraocular lenses six years after surgery. The originals are around 3500 pixels in the long axis, but I've scaled these down so that they don't take too long to download (hopefully). The one exception was the night shot, where I used and iPhone and a colour look-up table in Photoshop to represent day as night (the night shots I got from my iPhone already had unrealistic artefacts in them). Also, I was in the passenger seat at the time :)

So this is an indoor shot in bright, ambient light of a bunch of plants at about 3 metres. Note that I'm trying to represent binocular vision.



Note how focus and blurring is inconsistent across the scene. Also, contrast reduction; this is probably my biggest single complaint about these lenses, they make the whole damn world a grey blur. Thanks, Oculentis. Next is an outdoor shot in similar light with similar artefacts, at distances of about 10 - 50 metres:



One of the biggest problems I have is with seeing faces at work. I can be walking down the corridor and see someone only 3 or 4 metres ahead, but not be able to recognise them. And if I can, it's still impossible to see if they're making eye contact. It's a bit like this:



Reading is a problem. I'm not down to wearing reading glasses yet, just stuffing my face in to magazines. This is an example at normal reading distance:

(Damn; can't add any more files on this post. I'll upload it and reply - back in a sec).
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Oculentis faulty lenses! 02 Dec 2018 18:20 #13

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400 Swedes injured by faulty Oculentis lenses!
www.thelocal.se/20181127/over-400-swedes...ty-artificial-lenses

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Halos, Glare, etc. You know, the fun stuff ... 02 Dec 2018 15:48 #14

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www.ncbi.nlm.nih.gov/pubmed/28780781

Here is a link to an article from 2017, with direct quotes. (Highlights and bold mine.)

"Another important aspect of MIOL (multifocal intraocular lens) or EDOF(extended depth of focus e.g Tecnif Symfony ZXR00) IOL implantation is the perception of postoperative photic phenomena that can potentially compromise patient satisfaction. Generally, when light enters the pseudophakic eye, several mechanisms can disturb the ideal light distribution on the retina. This ultimately leads to a perception of a flawed or imperfect picture or even ghost images and shadows.

Positive dysphotopsia symptoms are described as bright flashes, arcs, halos, or sprinkles of light and are usually strongest in scotopic (dim) light conditions under which the iris dilates

Thus, halos, from a physics standpoint, are INEVITABLE with MIOL and EDOF lenses. This fact is highly relevant, as in a survey Mamalis et al showed that halos and aberrations are a potentially adverse effect whose occurrence represents the main reason for MIOL explantation.

CONCLUSION
It is important that the surgeon asks patients about their work and recreational activities to get as complete a picture as possible of each patient’s predominant visual needs. If, for example, manual or computer work is an integral part of the patient’s lifestyle, good intermediate vision should be supported by the chosen MIOL. If spectacle-free reading ability is strongly desired, an MIOL with a corresponding near addition might be the lens of choice. If both distances should be supported, a trifocal IOL would be suitable. Multifocal IOL defocus curves and capacities (Fig. 2) provide the surgeon and the patient with helpful information for this decision process.

As multifocality is usually linked with increased perception of halo and glare, the patient’s tolerance toward such photopsia also plays an important role. During preoperative consultation, the patient must be informed about the possibility of halo and glare
and the expected intensity for each specific lens type. A more relaxed personality with a readiness to compromise often indicates
higher compatibility with MIOLs, especially trifocal lenses, than a hypercritical and obsessive patient"

Interesting article which makes me wonder -

Were YOU asked in detail BY THE SURGEON (or indeed the office tea-lady) about your work and recreational activities with a view to establishing whether you could tolerate these side-effects and their impact?
Were you told halos were "inevitable", as they are according to the quote above from this scientific article?


I wasn't.

Lens Replacement Surgery and the "REAL" risk of P. C. O and Yag 02 Dec 2018 14:56 #15

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www.ncbi.nlm.nih.gov/pmc/articles/PMC5682778/

The above article states that Posterior Capsular Opacification (which causes vision to become cloudy) is a COMMON long-term complication of cataract surgery (which includes IOLs in this article)

"The rates of PCO following surgery are estimated to be 12% at 1 year, 21" a year 3 and 28% at 5 years after surgery".
I don't know about you, but 28% is an unacceptably high risk to me. It is glossed over in the "OE consent" documentation. How many people would say "No Thanks" if they were told the statistics?

The article goes on to say that treatment with YAG laser capsulotomy is effective, HOWEVER, complications, including retinal detachment, macular oedema, and increases in intraocular pressure, may also occur. The risk of retinal detachment is well known to be higher in myoptics i.e short sighted people.

If a retina detaches and cannot be repaired, you go blind in the affected eye.

Nightmare! 26 Nov 2018 13:36 #16

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Two years after my lens op performed by Dr Jan Venter, many letters of complaint ignored, term and conditions thrown at me, awful after-care, £50 charge for appointment after 1 year - I am in constant pain with both eyes, but the right one is considerably worse.
My eyes are watery, they feel sore and prickly. I feel like they are constantly being strained. In the morning my right eye is stuck together. My sight for reading is becoming increasingly difficult (this was the only part I was originally happy about)
When I read my eyes become painful, blurry and I can see something I can only describe as ‘blobs’.
My distance was never good after the op, but I feel it is deteriorating. I can only work on the computer for short periods of time. I intended to work full time after this op to help pay back the loan. I haven’t been able to do this, as my work consists of reading and modifying for profoundly deaf students and I know the pain would be too much.

Optical Express use hard selling tactics and then cover themselves in the small print.
My eyes are ruined, I’m in constant pain. I’m in debt. I paid a lot of money for a product that has not worked and put me in a worse situation than before the op financially and physically.

I am left with very painful eyes, SPK, clouding behind one eye and still wearing glasses. Nightmare!!!

This is just a brief summary of my experience. I thought 7 pages may be too long!
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Refractive Lens Exchange (RLE) - My story 21 Jun 2018 19:52 #17

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Hello,
I thought i would use this forum to give you my horror story with Optical Express (OE) so that others going through this awful experience know that they are not alone.

I work for the emergency services and decided to go to the free consultation with OE as they seemed like a reputable company that carried out a lot of eye surgeries successfully. When i arrived at the consultation with the idea of getting laser eye surgery to reduce my dependancy on glasses for my job, i was quickly informed that my eyesight was far too poor for that surgery however, i could get RLE surgery. When i was told it would cost me in excess of £6,500 i laughed and walked out as my public servant wage did not deliver those monies.
Within days i was offered a lower price with a better payment plan. I see the sales tactic now but at the time i was blind to it - no pun intended. My wonderful elderly father gave me the cash as an early inheritance and i booked the surgery, as i trusted what had been told to me. I was told of the minimal chances of any or all complications being less than 1% and told in the majority of cases these complications diminished as the patient healed. This included the minimal risks of haloes/glares/starbursts.
Within a day post op i knew something was not right. My vision was poor near and distance, i had day time glares and severe night time glares/haloes and starbursts, so much so that i could not return to work as the alleged 3 day recovery quoted suggested. In fact it would be three months before i returned to work. During this period I was frequently told that these symptoms would dissipate as time passed as it was very rare for them to remain. It was all down to my brain neuroadapting. Now this is a word that i had never heard of pre-op. After 9 months of having poor day time sight and having to wear glasses plus awful night time vision and a significant drop in confidence when driving at night, i was finally told i would need the multifocal lenses taken out and replaced with monofocal lenses. The risks were high. Higher than the previous surgery but i was advised it wasn't an uncommon procedure carried out there.
Obviously by this time i had lost all trust in OE and thankfully had found this site, so i started to research more into this phenomenon and found out the chances of haloes/glares/starbursts was nearly 40% in some studies!! In fact one of the OE surgeons stated he usually tells all his patients that they will experience these symptoms after this type of surgery as it is so common!!
If i had known about this i would NEVER of had the surgery as i am facing the prospect of losing my job if i don't have the risky explantation surgery. People may say, well its obvious why you say that now, hindsight is 20:20 (sorry). However, prior to the surgery i discussed monofocal implants instead of multifocal implants with the OE staff, as it was a cheaper option but decided against it as i was told my brain had to adjust to the lenses being at different focal lengths (which made sense) and this could take an unspecified length of time. This shows that i would have decided against any surgery that had a significant risk to getting back to my work quickly. And i was repeatedly told the risk of any complication was 1% and a percentage of that 1% had a risk of glares/haloes with an even smaller percentage of them not recovering. So going by that the risk of having glares/haloes permanently was less than 0.5%. Plain faced liars.
Currently i am weighing up my choices of whether to have the risky explantation surgery (10-20% chance of blindness) within the NHS or keep the eyesight that i have been left with and lose my job that i have loved for 20 years. Not an easy choice to make......

Saying It From The Heart 15 Jun 2018 06:46 #18

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Guy From North Wales wrote: Can I say thank you to those of you that have replied, sometimes you can read stuff and think how can they get away with all this. We live in a country where so much stuff is questioned under wether its politically correct and yet here is a company getting people to sign with no idea what they are signing because they are so carried away with this idea of better vision, the quality of the establishments that yes most of us get dragged in. But this isnt our nails or bigger breasts, its not cosmetic this is one of the most important things our vision. So for me some replies have really really helped and I can see I am not alone and indeed reading through the forum can actually see I am probably quite lucky.
Claire Foley I am going to try the doctors, mainly because I have psoriasis which is also stress related and this isnt in anyones interest the fact I am worried about my vision and losing one eye sight and not being able to drive. I went private rather then asking the NHS so now it has gone wrong I am not going to be proud but ask for help.

Hi,
I'm in a similar position to yourself in that I had rle surgery and suffer from.bad glares/haloes which mean I need explantation surgery through the nhs. However the risk of retinal detachment [20%] terrifies me. Is this the kind of figures you received?

MHRA 18 Apr 2018 18:47 #19

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Update to my 7 March post :kiss:



On 7 March I wrote, 'Bernie Chang, employed by Optegra, most definitely had an inextricable COI, and in my opinion therefore could not be considered ‘independent’, so why was he allowed to be part of the investigation?'

Not only was Bernie Chang previously Vice President and Chair of the Professional Standards Committee at the RCOphth, and one of the core members of the RCOphth Refractive Surgery Standards Working Group (RSSWG), he also colluded with David Moulsdale, and others, to remove me from my nominated position as RSSWG lay adviser in 2015*.

Not forgetting that OE’s very own Medical Director David Teenan** was also a core member of the RSSWG, 'to keep OE on board' otherwise they wouldn’t agree to the new standards, as Vice Chair Peter Tiffin told Shadow Chancellor John McDonnell during our meeting at the College on 4 December 2015 (arguing for my reinstatement after removal without right of reply).***

Points of concern:
• MHRA had discussions with and took advice from the RCOphth about the safety of the Oculentis MPlus X lens sold by OE and Optegra.
• Both companies have numerous legal claims from Px fitted with the multifocal MPlus X lens.
• Bernie Chang closely allied with Optegra and RCOphth.
• RCOphth has an indisputable track record proving that their allegiance is with members, not for patients damaged by their members.
• People still continue to contact me in 2018 reporting problems with the MPlus X lens (and other MF lens too).****
• MHRA is largely funded by drug and device manufacturers, the UK equivalent of the FDA - and equally as corrupt in my opinion.

'MHRA is funded by the Department of Health and Social Care for the regulation of medical devices, whilst the costs of medicines regulation is met through fees from the pharmaceutical industry. This has led to suggestions by some MPs that MHRA is too reliant on industry, and so not fully independent.’
en.wikipedia.org/wiki/Medicines_and_Heal...ts_Regulatory_Agency

Taken from a Daily Mail article published in February, 'The MHRA, along with other healthcare regulators around Europe, relies on a network of 59 commercially run ‘notifying bodies’ to approve the safety and efficacy of medical devices. But as Good Health has reported, the notifying bodies are paid by manufacturers to win approval for their products and the requirements for scientific validation are vague, say experts.

When asked, an MHRA spokesperson said: “We protect and improve the health of millions of people every day through the effective regulation of medicines and medical devices, underpinned by science and research.

Our role is not to protect industry interests. We have a full and transparent conflicts of interest policy which means that our staff cannot hold any interests in the pharmaceutical industry during their employment with MHRA."

MHRA chief executive Dr Ian Hudson told Good Health: “It is important to review and learn from how the healthcare system and regulators have handled these three issues, including how we ensure the patient voice is carefully heard. We will work closely with DHSC, the NHS and the wider healthcare system on this review. By all parts of the healthcare system working together, we can ensure patients are listened to and their concerns are addressed.
”'
www.dailymail.co.uk/health/article-54384...s.html#ixzz5D36XmE6s

I repeat, the stink of corruption oozes from every level of this sickening and unregulated industry, globally, and - quite frighteningly - extends to the government and EVERY single health organisation that the public are lead to believe they can trust!

* ‘others' notably included Moorfields surgeon and RSWWG Chair Bruce Allen, as subsequent SARs to Moulsdale and the RCOphth disclosed. And quite surprisingly to me at the time, David Moulsdale's disclosure was more honest than that of the College, whose CEO Kathy Evans dishonestly edited emails to keep info from me that I was entitled to.
**Top of the leader board with numerous RLE legal claims against him in Scotland.
*** OE didn't agree, don’t follow them, and have written their own standards with FODO.
**** Please contact me if you have any issues with implanted lenses. NB: VERY important that you report this to the MHRA via the Yellow Card Scheme @ yellowcard.mhra.gov.uk

Meanwhile, you may have noticed that my posts are fewer than usual. This is due to severe eye pain I've recently been suffering, so bad that I have to ration my time spent at the computer. And now I have hay fever to make it even worse!

Very frustrating because I have a backlog of news to post - and to those now breathing a huge sigh of relief because they KNOW they’re on my list, enjoy the reprieve while you can, it’s temporary!
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Scary facts 16 Mar 2018 12:15 #20

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More shocking facts about IOLs, intraocular lenses sold to people without cataracts, barbarically removing healthy natural lens simply to lose reading glasses - at huge profit to the industry.

Without cataracts this surgical procedure is termed refractive lens exchange (RLE), or natural lens replacement (NLR).

And as mentioned at the end of my 7 March post, it's not just the infamous Oculentis Mplus X lens that are problematic.

• December 2014, multinational pharmaceutical corporation Ocuentis issued an urgent Field Service Notice (FSN) and recall of its LENTIS HydroSmart intraocular lens.

• August 2016, multinational health care company AMO* (Abbott Medical Optics) issued a voluntary recall of intraocular lenses, following the detection of an inspection equipment malfunction that resulted in a total of 737 globally distributed lenses not being fully checked prior to release. FSN2016-02: Model Numbers ZCB00, PCB00, AR40e, ZLB00, ZXR00.

• September 2017, Oculentis issued a further Field Safety Notice applying to all LENTIS IOLs with model numbers starting with L-, LU- and LS- and expiry date between January 2017 and May 2020. Allegedly the lenses which have suffered opacification due to calcification are defective due to contamination in the manufacturing process.

As a patient advocate, over recent years I have spoken with countless numbers of people who have had - or need to have - their multifocal lens(es) explanted, not only those listed above.

A bilateral explant can cost £11,000 privately, beyond what the majority of damaged patients can afford to pay, so more frequently this is happening at significant cost to the NHS.

If you have post op complications with IOLs, and need further tretament, speak to a specialist lawyer before agreeing to anything with the provider, because you may be entitled to compensation, especially if the lens is proven defective.

In addition, it is important that you report the issue to the MHRA via the Yellow Card Scheme @ yellowcard.mhra.gov.uk



NB: To do this you need to know which IOL you have, and should have been given a lens ID sticker at the time of surgery. If not, you are entitled to ask the provider for this at no cost.



Optegra market refractive lens exchange under the Clarivu brand name, claiming, 'This proven treatment, carried out thousands of times by Optegra, is a technically advanced and sophisticated development of cataract surgery, which is one of the world’s most frequently performed surgical procedures.'
www.optegra.com/treatments/lens-replacement-surgery/clarivu/

Notice the absence of the 'safe’ adjective: one truth amidst their hype, because increasing numbers of Optegra damaged patients have contacted me in recent months, who are, in my opinion, being treated no better than OE's damaged patients.

Clarivu is unconscionably promoted by Ruth Langsford, lucratively paid over the years to tell people - without caveat - 'Do it, do it, do it!'.

And regular readers will remember that I met Ruth at one of Optegra's promotional dinners in 2015, her nauseating sales pitch intended to persuade people to sign up for Clarivu surgery by the time dessert was served - and yes, she actually said, 'Do it, do it, do it!'.

Before I was 'asked to leave', I challenged Ruth, asking how she'd feel if a person who'd had surgery because of her promotion was left with damaged eyes.

She insensitively replied that it would be nothing to do with her, saying, 'It’s like promoting shampoo, it might work for me but not for them'. (recorded)

Yet no such caveat in her advertising!
www.opticalexpressruinedmylife.co.uk/ind...a-clarivu.html#13850

And this conveniently leads me back to the MHRA, which I'll discuss further in due course.

*In 2016 Johnson & Johnson acquired AMO/Abbott Medical Optics for $4,325 billion!
www.jnj.com/media-center/press-releases/...bbott-medical-optics

Hence the ongoing fight to expose this corrupt and dangerous industry, because Big Pharma have plenty of cash to bribe government and health care organisations we naively believed were there to protect us.

No conspiracy theory - scarily the truth :kiss:

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