I am scheduled for cataract surgery on Nov. 30th, and the TECNIS Symfony lens (manufactured by Abbott Medical Optics, Inc.) is recommended. I am concerned because FDA issued a recall notice for these lenses on Sept. 21st of this year. (Recall #Z2857-2016, Event #75051) These lenses (about 737) were NOT properly checked prior to distribution. Has anyone had these lenses installed and needed corrective surgery or suffered loss of vision as a result of having the lenses installed.?
Lordy,
I am going to find out what I have...my vision is valuable...I would not accept an intraoccular lens on recall.
kind regards
The recall notice indicates that there was a failure in some inspection equipment. That doesn't indicate there is a problem with the lenses, merely that it is possible there might be. I've seen recall notices from the FDA for Alcon and Bausch&Laumb and other IOL manufacturers before when I was hunting through the FDA site for data on lenses, they are cautious with medical devices to play it safe. I would think that if anything it makes it likely the company will be more cautious after that to avoid more negative publicity.
I wrote to Abbott Medical Optics and asked if they could tell me how many people needed corrective surgery as a result of this incident and how they were effected. And, did this result in loss of vision or any other long term malady in any of the cases?
Their response was, "Any public information regarding an FDA recall is available on the FDA website. Any other information regarding patient status is confidential and/or proprietary." REALLY!
REQUESTING A NUMBER IS HARDLY CONFIDENTIAL AND ALLEGING PROPRIETARY INTEREST PREVENTS POTENTIAL PATIENTS FROM MAKING AN INFORMED DECISION RE USE OF THEIR PRODUCTS.
IF NO CORRECTIVE SURGERY WAS NEEDED AND THERE WAS NO LOSS OF VISION OR ANY OTHER LONG TERM MALADY THEN THEY SHOULD BE HAPPY TO SHARE THE INFORMATION.
I have not yet been able to locate the info I want from the FDA website.
I live in Canada, and had Tecnis symfony lenses implanted March & April 2016. I have been having ongoing problems with blurred vision, ghosting and significant halos and starbursts from car headlights at night. I am scheduled to have surgery March 2017 to have these lenses removed and replaced with basic custom monofocal lenses. I read that the recall notice was from the UK but it did mention that the 737 were globally distibuted, so I'm not sure if I got a pair of the affected ones. I just know that I am terribly disappointed with the results.
The "blurred vision" suggests the odds are either your surgeon hasn't appropriately corrected any residual refractive error (which can also cause some of the night vision issues you have). There is no indication there was any actual problem with any IOL, it was a precautionary recall.
There are people terribly disappointed with monofocals since they have a small range of good vision with each eye. Some with monofocals are terribly disappointed with the problematic halo and glare issues or starbursts they get, almost as frequently as those who get the Symfony. There is no IOL in existence that doesn't give some people night vision artifacts. Out of > 480,000 people or so getting premium IOLs each year, a small fraction have disappointing results, but unfortunately they are far more likely to post about them than those who have good results, so people need to keep the risks in perspective.
Its unfortunate that you had poor results, but that is the risk with any IOL since none are perfect. Others reading this need to keep in mind that the vast majority of people are happy with premium IOLs, but merely need to keep in mind the potential that they might be the "statistic" who isn't. If I'd gone with monofocals, I'd almost certainly have had a small range of vision. In my case I figured betting on the potential of a few decades of more convenient vision were worth the very slight risk of needing a lens exchange. It was a good bet, and if I'd wound up the rare "statistic" on the losing side of it, would still have viewed it as having been good bet (merely one that was lost) because no one can predict beforehand who will do well with a lens.
My surgeon is a very experienced and respected opthlamic surgeon having performed thousands of cataract, IOL's and eyelid procedures in Ontario and British Columbia and is an assistant professor at the University of British Columbia. I have had several follow up tests done post operatively in the last 12 months and was told to wait at least 6 months for the eyes to adjust, with no improvement. The cost of my Symfony surgery also included possible laser refractive surgery, if needed. I have had extensive testing done with this in mind, and was told that after testing, was told that neither Lasik or PRK would resolve my issues.
Hence my decision not to risk further Symfony lenses and have them replaced with monofocals. I have several friends that have had monofocal implants both very recently, and some within the past few years, and all have reported little, if any problems with night driving or other significant problems. I know there are no guarantees when it comes to eye surgery, but I am not willing to continue with the current blurred vision, ghosting when reading signs and letters and significant halos and starbursts with nighttime driving. I'll take my chances with monofocals.
Obviously if you have problems then you need to try another option. Most of my comments were addressed really to others reading your post who are considering options for surgery, for them to keep in perspective that your results are atypical.
The results may have nothing to do with the surgeon, but merely whether your visual system can adapt to the lenses, or other aspects of your visual system. Going for a monofocal lens *might* leave you with less problems with halo&starbursts, but no guarantee since some people get them with any IOL. LASIK or PRK might not address those sorts of issues (depending on their cause) which may be why they are recommending an exchange instead.
Its the issue of "blurred vision" which is puzzling, since you shouldn't have blurred vision if your eyes are healthy unless you have some remaining refractive error. Residual refractive error can be corrected with LASIK or PRK, but it may be that they aren't recommending it due to the halo issues those wouldn't address. If the "blurred vision" isn't due to refractive error, then its possible its due to some other problem with your eye, and that you'll have blurred vision with a monofocal as well.
Thanks for your feedback. I really can't explain why I have experienced all these adverse effects with the Symfony lenses. I appreciate that my symptoms may be atypical. Even my eye surgeon was very puzzled with my blurred vision & ghosting on reading signs & letters, although he did say that halos & starbursts were a fairly common issue that normally lessened after 6 months. Prior to getting the cataracts I have had better than average vision and had been getting good results with my annual checkup with my optometrist, and had no other vision concerns, other than the cataracts. I really hope that I can get better vision with choosing monifocal replacements but I will move forward with that decision.
I had my first cataract removal & Symfony Tecnis lens put in my left eye about 3 weeks ago. My first, second and third post visit to my surgeon went well healthwise, healing excellent, but vision poor in my left eye. Doc said that the lens that he put in may need to be removed and a replacement put in. I had double & blurred vision a well as seeing through a film of blue. which didn't seem to show signs of improvement between visits... and just not good enough to satisfy my surgeon. I have to give him major credit as he is determined to make it work. So we went ahead and moved the surgery up on the right eye... and that was done yesterday morning. This time my total in clinic surgery, eye tests etc., took about 3 hours. After the laser was used to break up the cataract, and then removed... I went into a room for additional eye measurements to be taken before the lens was put in. Once that was done... he determined the proper corrections, eyedrops being given during the waiting time. Then into the room to have the lens fitted. This was all different than the way the surgery prep was done three weeks ago for my left eye... measurements were all done at his office days before the surgery. Anyway... I was awake through everything except the insertion of the lens. I have not had any pain... other than when they put in the drops to dilate my right eye. I went home being able to see quite clearly with my right eye. Today I had my post operative visit, and my right eye sees 20/20, no blue haze, even with the swelling that is common the day after surgery. My doctor will reschedule me for removal of the lens in my left eye, measurements again will be taken and a astigmatism adjustment, new symfony etc., in a month. So for me... having him measure my eye after removing the cataract and before putting in the lens... made a difference, which he will do on my left eye as well. He explained the reasoning and how he came to change his proceedure. All I know is I can see as I should with my right eye. The cost of the second surgery on my left eye, I am not being charged for... Inconvienient, yes, but i am liking the results.
I am happy that, so far, you are very happy with your results. In my case I too was delighted with the results of my Symfony lenses after just a few short weeks of surgery. I was amazed how much clearer my vision was after the cataracts were removed and the Symfony lenses put in. I was thrilled that I could even read e-mails, messages and everything else on my small i-Phone screen without my normal 1.75 reading glasses. Even now, I can normally read without the readers unless the print is really tiny, even though with a slight blur and ghosting.
At medium or long distances this blurring and ghosting gets worse eg: when trying to read sub-titles on movies on the TV or on words on projection screens in my church at medium to long distances. My night time driving with oncoming headlights, flares and halos has not improved within the 12 months post surgery.
I was very interested to hear that your surgeon inserted the second IOL immediately after your cataract removal after further eye measurements were taken. I have never heard of that.
I wish you continued success with good results from post operative results for both eyes, not only in the short term but over a longer time frame and would like to hear your long term comments sometime.
At first there was a blue haze that was rather annoying in the left eye, however I now know it was caused by the drops that I had to put in twice a day. The bright colors are coming back. Color was good in the right eye from day one. My continued blur in my left eye concerns my surgeon. I am 20/40... and he said he wants to go back into the left eye and correct the astigmatism that seems to be there causing the blur. That is why he double checked the measurements when working on my right eye... between removing the cataract and inserting the lens. I have to return in two weeks to be remeasured and he will determine the next step then. I have less glare and halo with my right eye and it may get better than 20/20, however I realize it may stay the same. No matter, as my right eye is dominant and over powers my left eye, so my vision seems fine. I am thankful for a doctor that insists I have 20/20 or better in each eye. Seems the astigmatism is the cause of the blur and he thinks a different prescription and possibly tiny cut of some sort will correct the problem. I will trust him.
How are your eyes doing.
My next appointment is April 11th. We have yet to go in and address the blur in my left eye. My surgeon is letting the eye completely heal before he remeasures. It looks like he may re-shape the cornea. I still have a bit of astigmatism that needs to be corrected. My right eye has healed nicely. I am getting used to the halo's and the small glare. I can live with it. 😉
I recently had surgery to remove the Symfony lenses and replace with Tecnis monofocal lenses ZCB00 1 piece acrylic IOL. I had my right lens replaced March 10th & the left lens replaced March 24th. Both eyes are still in the healing stage & my surgeon says that it could take 4 weeks or more for any swelling to diminish. Because of some minor astigmatism in my right eye, the surgeon performed a limbal relaxation incision procedure at the time of lens replacement. This involves a couple of tiny incisions around the circumference of the cornea to induce the cornea to more fully return to a soccer ball round shape versus an oval football shape.
According to my surgeon, healing is proceeding nicely and I have 20/20 vision in my left eye. However, I am seeing a very faint shadow-like line in my right eye, kind of like an eye lash in my eye (which it isn't ). The surgeon tells me this could still be part of the healing process and should normally resolve after 4 weeks or so. My vision is still quite blurry in my right eye. I told him that I also experienced this strange faint shadow effect with the Symfony lens, which lasted for a year. He said the other possibility is that it is a slight light reflection on the underside of the lens. I asked if this could be fixed if it persists and he indicated that it couldn't which leaves me a little concerned if it doesn't resolve.
I suspect the odds are that the FDA limits what data companies are allowed to release to prevent a public given only partial data while an incident is still under investigation which might be misleading from worrying inappropriately. Many people underestimate how much government regulation can lead to unintended consequences in terms of how companies operate. Patient information needs to be kept private, which is I suspect the major concern with the sort of questions you are asking. It would seem rational that aggregate data without patient identifying information could be supplied, but unfortanately the various rules sometimes unintended consequences of making that information hard to collect or report on, even if the answer were 0 patients.
Unfortunately in other industries I know of people who were frustrated they weren't allowed to release information that would calm people's fears, and releasing partial information would have left people with the wrong impression.
I suspect that during that that every other IOL manufacturer would make similar comments since if they aren't allowed to release everything to put the incident into context to give people the "whole story" they are hesitant to release partial information. I'd suggest asking other IOL manufacturers about their recalls and you'll see the same answers. If the information were available, reporters likely would have covered it. Whether or not we think the FDA is doing a good job, they presumably dictate what information they claim is appropriate for the public to have access to and companies rationally are going to follow the standard they set, even if in theory they might be able to provide more information. They also realize that incomplete information may be misleading.
In the world of safety if there were *never* a recall then there should be natural concern that safety protocols might not be stringent enough. Given that in the real world all humans are fallible and accidents happen, with > 20 million cataract surgeries a year worldwide, occasionally there will be a recall from the major IOL manufacturers. An occassional recall suggests the system is working.
oops, I should have said "an occasional recall suggest the system may be working", we can't know for sure if the protocols are designed appropriately or not.
Hopefully the remaining issues will be heal over time.
The astigmatism they felt a need to treat sugggests you had astigmatism when the Symfony lenses were in place, which could have been treated prior to trying a lens exchange (those limbal relaxing incisions can be done without getting cataract surgery or lens exchange surgery).
The residual astigmatism may have been part of the problem with the Symfony that led to the other issues you described since residual refractive error can impact even things like halo prevalence (and perhaps treating it might have resolved the at least some of the issues and perhaps led to not feel a need for replacement, but some surgeons like doing surgeries if you'll pay for it).
It sounds like at least one of the complaints wasn't fixed by a replacement. If you had the sort of dysphotopsia you describe then I gather most surgeons use an IOL with a different size/shape/material rather than merely using a monofocal with the same overall size/shape/material as the lens they are replacing. I'm wondering if you ever bothered to get a 2nd opinion before going to the trouble of getting a lens exchange since I suspect another surgeon might have given you different treatment options. Ideally people should get 2nd opinions before any surgery, but especially before any sort of surgery intended to correct a probematic result from a prior surgery.
As I am still in the healing/adjustment stage I think I will wait a while longer until I can assess true results. I was told that I would need reading glasses again after the surgery, and this is the case, with clear vision with 1.75 readers on my iPhone, iPad and laptop. My intermediate and long vision are good. It's too early to evaluate my night time driving with halos.
As far as costs involved, the costs of my cataract surgery, Symfony lenses, and included possible further laser refraction was a total of $5,200. I have had many follow up visits, eye tests etc for Lasik surgery, which my surgeon felt would not help or improve the problems I was having. In actual fact there was no further cost for the second surgery to replace the lenses, and I was even refunded $2,000.
I am interested to see if you have now seen any improvement in eliminating halos and concentric circles. I am in a similar situation to you. In November I had symfony lenses implated in both eyes and from day 1 have had an issue with halos and concentric circles. I am currently limited in ability to drive at night. Shortly I will be under going an evaluation for a lens exchange --- Monofocal for distance.