Faulty replacement lenses
Posted , 10 users are following.
6/7 years ago at Optegra I had Clarivu lens replacement surgery with excellent results - I am naturally very short sighted and needed to use reading glasses too. I needed yag laser surgery shortly after the initial operation to clear some scar tissue. In the last year or 2 my vision has become increasingly "cloudy", almost like looking through a cloud. My optician referred me to the Manchester Royal Eye Hospital who did more yag laser on one eye only but said that the lenses themselves were becoming cloudy. After contacting Optegra a few times over the last 6 months I was eventually seen today. I was told that I was one of an unfortunate few who were given a batch of replacement lenses that are faulty and become cloudy. The remedy, they say, is to another operation but the new lenses will be able to correct short sightedness only and I will need to use reading glasses. The new operation will be more difficult and take longer because the yag laser performed has made it impossible to use like for like lenses. Optegra say I shouldn't have to pay for this new surgery but will let me know when I see a doctor - very strange since I was told, at the time, that Clarivu lenses were for life and that I would never get cataracts. Has this happened to anyone else? Am I in a small number of people who were given lenses from this faulty batch? Is what they're offering me the only option or is it their cheapest option? I'd be really grateful to hear from anyone this has happened to, what they're being told and how they're handling the matter. Thank you
1 like, 9 replies
RonAKA janet61215
Edited
After a little Google research I think that Optegra must be the name of a private eye clinic in London England? If so it appears that this Clarivu lens you refer to is actually the name of a package deal to replace the natural lens in your eyes. It is not the name of the actual lens. Did you have cataracts, or did you go for this package to correct your vision issues? This is what I found about Clarivu:
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"The package includes: all diagnostic eye assessments, an artificial intraocular lens (IOL) specially selected for your lifestyle and visual goals, the procedure undertaken in an Optegra eye hospital and post-operative care. In addition, the Clarivu package includes any further top up laser surgery that may be required in order to meet your stated visual goals. The Clarivu package means you pay one single price for the consultation, procedure, lenses and aftercare – no matter what your prescription."
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Then when you drill down on the IOL lenses they use, it just lists the whole range of available lenses from basic monofocals, to torics, and multifocal lenses. There is no mention of the actual manufacturer or model versions of the lenses. Clarivu is not a name of a commercial IOL to my knowledge, and I suspect just the name of the package deal. From what you describe you probably have gotten multifocal lenses to get both near and far focus. Where I am in Canada you get a small credit card sized card with the exact model number, power of the lens, and serial number of the lenses that is used in the surgery. You would have to look at this card to find out what lens was actually implanted. Or, perhaps it is detailed in the paperwork with the package information.
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It is not unusual for vision to become cloudy from posterior capsule opacification (PCO) after implantation of an IOL. This is not the lens itself getting cloudy, but an accumulation of cell growth in the capsule. It is normally corrected by cutting a hole in the capsule with a YAG laser. The actual lens is normally good for a lifetime and should not get cloudy. One lens material made by Alcon has had some issues with what is called glistenings, but it is rare for them to occur to the point where the lens has to be replaced. But, I guess with a bad batch anything is possible and even from other manufacturers.
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But, yes, there are issues with a lens exchange after you have cut a hole in the capsule with YAG. I am not familiar enough with those complications to comment on whether it is necessary to use a basic monofocal lens instead of a multifocal type. This limitation may come from the use of a different lens fixation method to keep the lens centered in the eye than is used with a standard lens. If you wish to maintain the ability to read as well as see distance there is the option of monovision. Monovision normally uses basic monofocal lenses. The dominant eye is corrected for distance, and the non dominant eye is corrected to leave it slightly myopic at about -1.50 D. I saw in the Clarivu package material that monovision is an option that is offered, so Optegra should be quite familiar with it. I am using monovision that lets me see from about 12" to infinity quite well. It avoids some of the issues associated with multifocal lenses such as halos and flare around lights at night.
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Hope that helps some. If you can find the actual manufacturer and model of the lens then that would be helpful in getting further comments on how common this issue is.
soks janet61215
Edited
sorry you are going through this. was your iol mplus oculentis? iol opacification was known problem with these lenses.
RonAKA soks
Posted
Yes, I found this on line:
"THE Food and Drug Administration (FDA) calls for product recall of all Lentis Intraocular Lens (IOL) distributed and imported by Ophthaswissmed Philippines, Inc. with expiration dates between January 2017 to May 2020.
According to the official statement released by FDA, Oculentis BV, the manufacturer of the said item “received notifications of sporadic late postoperative opacification of Lentil IOLs.” This, in the long run, may compromise the optical transparency of IOLs which may lead to a “slow reduction in the patient’s visual acuity.”
Included IOLs products are the Lentis (MDR-04652), Lentis Comfort (MDR-04654), Lentis T Plus (MDR-04647), Lentis T Plus X (MDR-04707), Lentis Comfort Toric (MD-04708), Lentis M Plus (MDR-04651), Lentis M Plus X (MDR-04653), Lentis M Plus Toric (MDR-04719), and the Lentis M Plus X Toric (MDR- 04706).
Studies made by Oculentis BV suggests that the opacification may have been led by the phosphate remnants present in the cleaning agent used in production. They assured that currently produced and those IOLs with expiry dates of June 2020 and later are unaffected and can be used safely and effectively.
FDA advised healthcare professionals and establishment to discontinue use, sale, and distribution of the affected product."
Goldcat soks
Posted
My replacement lenses back in 2014 were OCCULENTIS M PLUS X.
They have been fine until recently , I have now noticed that my sight is deteriorating.
Sue.An2 janet61215
Edited
Was there ever a class action lawsuit against this faulty lens? You may want to join.
Very unfortunate as there is no solution but to exchange the lens - and that is a far more riskier procedure which you should investigate thoroughly. You will want s someone who specializes in exchanges
Goldcat janet61215
Posted
I also had replacement lenses back in March 2014 followed by YAG laser with excellent results for both reading and distance vision.
i have recently noticed that my close up eyesight is deteriorating and i have also become aware of faulty lenses. mine being, OCCULENTIS LENTIS M plus X
I am due to see my optician, I am worried a out the future.
anne06749 janet61215
Posted
Hi Janet,
this all looks rather old so I just hope you may see this. Your description of what has happened to your lens is exactly my experience. I have recently complained to Optegra and asked for a refund and compensation but have received a very poor response basically passing the buck to Topcon who I assume are the manufacturers. They have offered to do a replacement op despite their surgeon telling me that should be a 'last resort' as it was not without risk which is confirmed in your responses. I wonder if you have made any progress with this? I am aware that a group were successful in claims against Optegra. I have tried numerous lawyers but no one will take it on, I think as an individual it isn't worth their while. Please let me know what your situation is now. Anne
jillsussex janet61215
Edited
Hi Janet - i hope you read this or anyone else.
I had lens replacement privately at Optegra in Guilford. this was May 2015. i was told they would be for life. Recently I have had failing eyesight in my left eye with clouding. i was told by my optician it was a common problem of cell growth that could be lasered in seconds. when I went to have this done on NHS I was told to go back to Optegra. I was seen the next day by Optegra and after scans etc told that the lens they used was a faulty batch !!!! the lens has to come out. I now have been referred to an eye surgeon in Hampshire ( 2 hours drive from me) i am very scared as been told the op is quite difficult and i probably will have to wear glasses.
there was a notice sent out in 2015 and 2017 stating the lens i had may be faulty!! Why was I not informed. i have been told I will not have to pay for the op but I should never have had to go through this. i would love to talk to anyone else who has had the same experience
RonAKA jillsussex
Edited
A IOL lens exchange is more difficult than a natural lens replacement, but it is done. You should find a surgeon experienced at it. They normally chop the lens in half and then pull the two halves out, one at a time. And, then insert the new lens of course. Hopefully you have not had the YAG procedure as that does complicate things as there is a hole in the back of the bag that holds the lens. But, a replacement can be done even after a YAG has been done. It may limit the type of lens that can be used though as you have to keep the lens haptics inside the bag that has a hole in it.