TECNIS SYMFONY LENSES RECALLED BY FDA-ANYONE SUFFERED LOSS OF VISION
Posted , 28 users are following.
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.?
0 likes, 81 replies
barbara74207 Eclecticlz
Posted
lin59 Eclecticlz
Posted
For anyone considering a Symfony lens vs. an aspheric monofocal lens, this is from the Abbott official brochure for the Symfony lens:
"The TECNIS Symfony® IOL may cause a reduction in contrast sensitivity under certain conditions, compared to an aspheric monofocal IOL. The physician should carefully weigh the potential risks and benefits for each patient, and should fully inform the patient of the potential for reduced contrast sensitivity before implanting the lens in patients. Special consideration of potential visual problems should be made before implanting the lens in patients with macular disease, amblyopia, corneal irregularities, or other ocular disease which may cause present or future reduction in acuity or contrast sensitivity. Because the TECNIS Symfony® IOL may cause a reduction in contrast sensitivity compared to a monofocal IOL, patients implanted with the lens should be informed to exercise special caution when driving at night or in poor visibility conditions. Some visual effects associated with the TECNIS Symfony® IOL may be expected due to the lens design that delivers elongation of focus. These may include a perception of halos, glare, or starbursts around lights under nighttime conditions. The experience of these phenomena will be bothersome or very bothersome in some people, particularly in low-illumination conditions. On rare occasions, these visual effects may be significant enough that the patient may request removal of the IOL."
https: // www. vision. abbott/ us/ iols/ extended-depth-of-focus/ tecnis-symfony . html
tim20129 Eclecticlz
Posted
I had Symfony lens replacements 2 and 3 weeks ago (R and L eye separate). They work very well. I believe a person's willingness to accept the unique artifacts of any replacement lens depends on their prior vision: if you are accustomed to 20/20 vision at distance (unaided), then be prepared to see some new "features", especially at night. In my case, I was very nearsighted (10.5 - 11 diopters) so the Symfony is a welcome relief to my coke-bottle glasses, with all their distortion. The Symfony gives very good focus at a range of distances (rather than "perfect" focus at 1 distance). My surgeon optimized my left eye for "very good" vision from about 1 to 10 feet out; and my right eye for ~7 feet to infinity. Results are fantastic, my combined vision is almost 20/20 for all ranges. At night, I see interesting halos with small rings around each light - but I think they're kinda cool.
betwixt tim20129
Posted
I'm happy that you are doing ok with your new lenses. Do you drive at night? I find the symphony unworkable for night driving -- but as long as I do not have the "artifacts" in my dominate eye, I think I can cope. (I am very near sighted) I will be going for a standard monofocal for the right eye. As an attorney, when I read a precaution by the manufacturer that special caution needs to be taken in night driving, and I know that in my case, no discussion of potential adverse effects were ever discussed, let alone a flat out precaution for night driving -- I see a potential of an ophthalmologist joinder in lawsuit if there is a car accident.
Sue.An betwixt
Posted
betwixt Sue.An
Posted
Hi, Sue.An It's been three months -- I see no difference. No problem with daytime vision, just night. As a 50 yr wearer of contacts, I have always had halos -- but this! No comparison for me.
annette37130 Eclecticlz
Posted
I am a new reader on this site and was interested in how you are progressing. I just had the same lens implanted in my left eye and am scheduled to have the other eye done next week. So far I am happy with the lens with one exception. It seems that I can see the edge of the left side of the lens, especially in bright light. (Its hard to explain exactly). I am waiting to see if this condition improves with a little time, although it hasn't changed in 3 months.
kay_61443 Eclecticlz
Edited
Hi there. i saw that edge also on both eyes for a good while. it is gone now in the right eye and i think it is gone on my left but am not really sure. sometimes i think see something odd out of the left corner of my eye but it no longer appears to be a light reflection. i can see pretty well now but i do have starbursts and halos and glare and concentric circles and ghosting especially white letters against a dark background on the tv screen. when i turn the lights out - my tiny DVR clock becomes a big colored halo. i see starbursts around pretty much all led lights all the time and moving halos and concentric circles around others and even around the windows where the outside natural light comes in. But the starbursts outside are by far the worst. they are huge around car lights even before dark and they worsen as the sun goes down. the street lights and stop lights have halos and starbursts depending on what type light. i live in the city so lots of lights. . i no longer drive at night -- the starbursts are so big and intrusive. regular shaded lamps indoors are not a problem. . i do see smaller starbursts around the led lights in my fridge and my christmas tree lights.i am curious to see if you see any.it has been 7 months on my right eye and a little over four on my left and the artifacts have not lessened but my right eye has a small amount of residual nearsightedness and astigmatism and i have pco from the beginning but it is not pronounced yet. the fact i am nearsighted in that eye allows me to see better up close though. . i went to a different surgeon for the left eye which also has a small of astigmatism so some of my grief may be caused by that and dry eye. the good news i have not even worn drugstore glasses since the second surgery.that is pretty amazing since i wore gas permeable contacts forever as my farsighted astigmatism was so bad. it is possible the artifacts will improve as i adapt but it has not thus far. i plan on going to a cornea specialist just to be sure there is not something else besides the lenses also causing these artifacts that can be corrected.i am loathe to have them removed and replaced.i wish i had better news for you. i think i am just one of the unlucky ones. had i known this would happen - i probably would have gotten toric lenses only and worn drugstore glasses for reading. I am interested in hearing about your progress. Wishing you the best kay
paul07903 kay_61443
Posted
Hi to those people who have had problems with their Symfony lens. I count at least 4 on this blog, starting with Lloyd, who have had almost the same exact issues as me - guess we are not alone. I am 58 and had a rare progressive posterior cataract in my right eye that was starting to blur my vision. Note that never has any glare or floater issues. After much research, being in the pharmaceutical industry, my surgeon and I agree the Symfony lens were the best option to maintain my lifestyle, increase my chances of being free of glasses and reduce the probability risk of vision aberrations. Despite a difficult recovery, my vision overall is really great. I have 20/20 in both eyes and can read my computer and only have to put on reading glasses in low-light and small-font situations like a newspaper. However, the halos, light arcs, perfectly shape concentric circles, white ghosting of letters on black background, huge starbursts that started on day one and was told would go away have continued now up to 11 months post-surgery. My surgeon and his colleagues have never seen this before with Synfony lens and claims I am a rare outlier. Until recently, my surgeon seemed to be only obsessed with how well my visions is and dismissive of my "glare issues." They are all their in the day by only 10% of what I see at night. I am finding driving so distracting and night in general in the city feels like I'm trapped in a pin-ball game of lights. Night time driving is getting to be unbearable especially headlights on a single-lane road and the associated blind spots on the bottom left of the road like a divider. On top of all of this I have since developed floaters that look like single-cell amebas drifting along and lashes/spider webs on the edges. I think I can live with or mentally block out the floaters but not sure I can live with the challenges of night driving especially when I get older and into my 70s+. I am talking with my surgeon now about the pro/cons of replacing them with mono-lens: currently trading off great all-around vision and trying to live with all the night time glare issues with the potential for great far distance vision, need for reading glasses for even computer work, a good change that I'd have much less glare but with no guarantees that the glare issues would go away and the possibility of increased floaters from repeat surgery. I am looking for any positive stories on replacing the lens to give me the courage to do so or just try to live with the situation. Boston Paul
kay_61443 paul07903
Posted
Hi Paul. sorry that you are going through it too. It has been a year since i posted about my issues and nothing has changed except for the worst. i am now farsighted in my left eye and still nearsighted in my right with some astigmatism and pco in both. and i am not 20/20 in either eye. other than that your description of your issues could have been been written by me. i am at that age that you are rightfully concerned about. i don't dare drive at night anymore. the starbursts start in earnest at the first hint of twilight or in fog or rain. the surgeon who did my left eye surprised me at a checkup by insisting on doing yag on my right one in august . I protested that i had read some less than favorable information but he insisted it was cake. it was not. Ever since then i see a few extra long lines of starburst coming from the bottom right of the starbursts that I see around all led type lights. but the long glare lines by themselves are often there on other type lights that do not cause starbursts. i also see smaller starbursts on natural light sources including coming through the windows and bouncing off cars during sunlit days. I avoid looking at my LED kitchen lights to keep the anxiety at bay. in oncoming car lights the extra long starburstlines literally stretch from all the way down to the street to inside the car with me . that did not happen until after the Yag but no one can explain that one either. i asked if the lens was perhaps scratched from the Yag laser surgery that hurt for days afterwards or was there a fold in the bag as what i am seeing seems to be a maddox rod effect.Was told no.i am afraid to have them replaced. but i am ruing the day i was talked into the symfony lens. i needed torics but i did not their version of multifocals. good luck Paul. let us know if you do decide to replace them. kay
Sue.An2 paul07903
Posted
Hi Paul
That is a tough decision to make. Especially if you have great daytime vision. there is certainly more risk in having an exchange vs cataract surgery so if you do decide on that course of action look into a different surgeon who has plenty of experience in doing exchanges.
I gave 2 Symfony lenses (for over 2 years now). Although I do see the perfect concentric circles I am not as bothered by them as I was. I don't live in a city with multiple highway lanes (2 at best) so perhaps if I was navigating with 6+ lanes it would be more difficult. I see well during the daylight and just faint ghosting of white letters on dark backgrounds. Nothing significant and inside lights are fine - glare was very bothersome when I had cataracts so this Symfony view is much better than I had.
One thing if you are considering an e change - do not get a yag for pco as that would make an exchange difficult if not impossible. Let us know what you decide and how it turns out as I am sure many contemplate exchanging lenses.
paul07903 kay_61443
Edited
Thanks for your response Kay after posting a year ago! I'm sorry that your situation has not resolved. I was told not to undergo Yag in case I end up replacing my IO lens in the future as I guess the procedure could be more complicated. Sorry to say. I have an appointment coming up and will keep you posted on what I decide to do. Happy New Year! Paul
paul07903 Sue.An2
Posted
Hi SueAn, Thanks for your reply. I'm glad that in the end your glare issues are less post the Symfony lens. I think I am struggling because I had experienced not glare what so ever before and all these unexpected glare artifacts was exactly why I paid so much out of pocket to avoid with these lens! Yes, I see really great during the day and live with things like the glare from Christmas tree lights inside or LED clocks, etc but the night driving can be so distracting and dangerous. The other night carlights going by on me on an single lane essentially blinded me and I didn't see a couple walking across the street in front of me and came from behind the other car and I almost hit them. It was scary. I'll let you know If I decide the trade off risk is worth going for an exchange. Happy New Year to all affected! Paul
kay_61443 paul07903
Posted
yes i was aware it would be more complicated and was not planning on having it done as i said earlier. i came in for a regular check up on the eye he did and he sprang the Yag on the other eye on me and i reluctantly allowed it. silly me. In his defense, he had asked me earlier if i wanted to replace them and i told him i was not convinced it was a good idea because i would be very upset if i did that and i still i had vision problems - the same or different. Never checked to see if the patient is responsible for all the costs.
My retina dr who does lens replacements does not think it more complicated but i think i will go with the majority opinion on this. Good luck Paul.thanks much for keeping us posted and for the new year wish . And a very happy New year to you and yours also. Kay
soks kay_61443
Edited
the yag probably pitted the lens. in cruciate method they do an X pattern laser. that is what you are probably seeing?
kay_61443 soks
Posted
Hi there Soks. My research led me to that right after it was done. I asked my surgeon and my retina dr who i just saw about a month ago if the lens was pitted or scratched or if somehow the bag had been creased as the streaks are just like the maddox rod effect that happens when the bag gets creased during cataract surgery. But I did not find any instance of that happening during Yag laser surgery. I was told nothing was wrong by both of them. i did say something during the surgery and he immediately ceased using the laser. if damage was done it was probably then.Makes little sense to me that it occurred immediately following the yag surgery which burned for days afterwards but there is no damage. I think i am going to schedule an appointment with another opthalmologist.. i see the starbursts like others but a few lines of the starburst extend way beyond the rest of them. in the case of an incoming cars, as i mentioned in my previous post, the lines literally extend from the oncoming headlights to me inside of my car. at home it extends from the kitchen lights halfway to the floor and i have 11 foot ceilings. And in streetlights and porch lights - it extends a few feet. If i turn my head the lines go with it. i do not know if he used the cruciate or the circular method. thanks for your response. Kay
soks kay_61443
Edited
hi kay. after YAG the bag is pretty much gone so it should not be a fold/crease in the bag. what you describe has been described by others after YAG. cruciate is the recommended method as it reduces the possibility of floaters but the risk is pitting in the visual axis. circular method causes more/large floater but the pitting is outside the visual axis. it is good you saw a retina doctor as you are not supposed to feel anything during the procedure.
soks
Edited
it could also be the opaque edge of the remaining capsule. i see a right tail of light and have not had YAG yet.
kay_61443 soks
Posted
Hey Soks.right tail of light? the only reason i even considered the bag is because it looked just like a maddox rod effect and i was straw clutching as i could find nothing that described the effect other than that. it was definltely not there prior to the yag. i already had the retina dr because of a macro-aneurysm that showed up out of nowhere and hemorrhaged before i had either eye done. not diabetic. and havea little higher blood pressure when stressedAll i had was a little purple blob before i saw him. my optometrist sent me to him on an emergency basis. he gave me a shot in my eye which he said could make it worse and boy did it. it took my vision right out in that eye for 5 or 6 months. a few days later he patched it with the laser which worked. after the blood drained i had the first eye done. and the only reason i went to that surgeon is because he strongly suggested i take him over my other choices. big mistake.that eye has never been close to right. I am rapidly losing my faith in doctors all around these days. I do not know which method he used but the cobweb type floaters are worse than ever.i will google the opaque edge issue and see it corresponds at all. did not see that in my earlier researchthanks for the heads up. the procedure itself did not hurt. but the minute it was over my eyelid felt like it was 4 times its size and hurt and burned for days. He only put a small hole in the bag which could be the reason for the new effect. but he said he would not put me through it again. i told my retina dr about it and he said no the hole is big enough.. the floaters never subsided. Good luck to you. Kay
soks kay_61443
Edited
hi kay. sorry you are having to go through this. this ordeal is by no means 'routine'. i am going to have to get YAG soon and feel lost for options. i already have positive dysphotopsia and worry that YAG will make it worse. i am holding off because i have not yet decided if i will exchange the lens. preference would be to not exchange.
kay_61443 soks
Posted
Thanks I am sorry that you too are having such problems. i was as indecisive as you and would still be there had the surgeon not sprang the YAG on me and i caved.i also have PCO in my left eye - the one he performed cataract surgery on but i told him he would have to hold me down to do yag on that one as i see much better with it.why do folks get PCO so early with these lenses? they have just as many issues if not more than the regular multifocal lenses. good sales job. you have good reason to be concerned. but my sister had YAG twice and was fine but she has the regular monofocal lenses.i do not know anyone who is anything but happy with those. i have a couple friends who got regular multifocal lenses years ago and have no issues. my preference also was and is to leave them in place as disturbing as all the starbursts and halos and glare etc are. keep me posted soks.. my best to you. Kay