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class action

Is there a class action suit pending or being organized against manufactuers of ReStor IOL multifocal lenses?
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Avatar universal
I hope you read the comments I just posted, do not give up i know how you feel! ***@****
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1 Comments
Avatar universal
First, I agree that most class action suits don't actually accomplish much.

Second, I would be more inclined to sue doctors who don't disclose known potential problems with the lenses. Many people are perfectly happy with Restor lenses, which implies that they are not inherently "bad" or "defective". They just don't work well for everyone. Patients need/deserve to know before having the surgery what the known/expected possible risks and complications are. Based on the posts in this forum, many patients are uninformed.

Note that I am NOT a fan of malpractice suits. I think most of them (probaby 90% or more) are without merit. I understand that in any medical procedure, there are many unpredictable things that can go wrong, and I do not think doctors should be held accountable for those, except in the very rare cases that they are truly negligent.

However, this is a very different case, where there are well-known and potentially severe problems, and full disclosure should be mandatory. When the lenses were new, it was understandable that the side-effects would not be known. After a year or two, there was no longer any excuse for a doctor to either be unaware of the issues, or to fail to disclose them.
Helpful - 0
2 Comments
After having a procedure and your life completely changes, wearing sunglasses all day everyday, eye drops such as expensive prescription RESTASIS, GenTeal jel drops, and many other prescription drops since 2012 and nothing has helped, the only relief is sleeping. My eye's jolt ( like an earth quake) then the left eye will start shutting like a shutter on an old camera   and goes black is scary, my vision restored in a matter of  10 to 30 minutes after this. I am not a person to sue as well but if the lens are defective and I may eventually go blind, the cost if their is a chance for a transplant, or surgery to restore my vision will be costly, or may have to live with blindness. The pain I deal with and clarity is so frustrating, their are day's I feel like my head is in a fog I can not even think clear, usually my eye's are acting up! I have to differ with you, I have read many complaints those that had ReSTOR Multi focal lens! They are under the impression they are going to have to live with it! Imagine living with a slight coat of vasaline in your eye and someone blew dust in your eyes! Every place you go in the florescent lighting is so painful! So Peakhope this is not a matter of a class action lawsuit! I would appreciate a good lawyer represent me! I would like to know who should be held responsible? It may have only been the lens that were on recall that were defective! There may be some people that did not get the model recall numbers and are doing fine!  Trust me... I wanted the procedure, walk out of the office after the follow up and never have to  go back hoping they would improve in time, I have spent 3 1/2 years in misery!
=
Avatar universal
I think there needs to be a class action suit.  But then again only the lawyers get rich.  
Helpful - 0
4 Comments
I do know there has been a recall on April 15, 2015 by the manufactures, no one notified me I came across it looking at the FDA recalls! They are trying to say it was lens they sent to Japan, well I can tell you the ReSTOR lens in my eye 's have the same model #! I have posted this everywhere trying to get legal help!
I had the ReSTOR Muliti focal Lens procedure, since that day October 13, 2012 I cannot put into words how my life has drastically changed, constant pain, constant vision problems, and the feeling of despair is unbearable. I have researched for years trying to find an answer to my problems. The doctor that did the procedure was no help and seemed not interested and acted insulted. After many years of research, a couple weeks ago I came across an FDA report, the Alcon manufactures makers of the lens have a recall on the exact lens that are in my eye's...model #SN6AD1, I understand Alcon are trying to say the lens with these model numbers were 'all' sent only to Japan and did not effect Americans, but my model number is one of the numbers on recall... I knew something was wrong all these years!
I presented the proof of recall to the doctor that did the procedure in 2012 and he is now giving me attention for my concerns. I had a procedure free of charge by him April 27, 2017 that is suppose to help with dry eye's and improve my problem but my eye's are getting worse... it was no help at all! What I am dealing with, I feel is beyond dry eye's! I am actually scared I am going to eventually be blind. I live everyday in misery, the problem with my eye's even clouds my mind... I feel like I am in a fog and cannot think clear! The ReSTOR Mulit focal lens in question are on file with the FDA, the recall is number Z-2323-2015, I found this on my own, my eye doctor acted like he knew nothing about the recall! I understand the FDA require Alcon Laboratories makers of the lens to notify the doctors that used these model numbers? I have read hundreds of comments about people dealing with the same issues as I!
From the day after the procedure my life drastically changed, and continually getting worse! I understand from some people getting second opinions that wanted the lens removed, if a patient for ReSTOR multifocal lens had the YAG (laser polishes the lens) procedure done after the ReSTOR procedure.... it seals the deal and any attempt to have them removed is a 50/50 chance it can result in blindness!
The ReSTOR procedure was for eliminating reading glasses, it has 3 levels close-up, far, and medium vision. Close up was my only problem! It has ruined the quality of my life and sure thousands of others that had the procedure are ruined as well! I still see halos around lights, my eye's ache constantly, both eye's vision is like there is a film of Vaseline across them they are never clear, feel like and like someone blew dust in my eye's, never clear and have a constant nagging pain! Constantly putting drops and gel in my eye's for relief, it only helps for as long as they are in my eye's! To let you know how my eye's feel 1) after you have been in a heavily chlorinated pool have the same feeling constantly. 2) Dust has been blown in my eye's 3) I cannot be on the computer more than 30 minutes at a time, my husband has to finish filling out forms and complete anything I am engaged in! 3) Trying to find a job, my eye problems hindered me from getting the jobs I applied for, the florescent lights and most all jobs require computer... I am limited how long I can look at a computer screen! I have to put my head back, close my eye's to rest them through out the day 4) I cannot wait to go to sleep it is the only relief I get when my eye's are shut or sitting in a dim room! 5) I can only be in stores for a very short while then the glare of the florescent lights increase the pain, can no longer read shelf tags! 6) I have to wear tinted safety glasses all day in-order to function defeating the purpose for me having the ReSTOR Multi focal lens procedure originally! Thought I was getting rid of my cheaters, and be done with glasses forever...what a major mistake! What I would do to get my God given lens back!
I would appreciate your advise on this issue... should I call Alcon Manufactures makers of the ReSTOR lens or should I get a lawyer involved? Alcon Laboratories making the comment about "the lens recalled were those that went to Japan" sounds like they are trying to cover themselves in the US... my lens model number was on the recall, I feel like I am going to get the run around! Quantity in Commerce - 45,391 I feel sure my lens are part of the recall and do not need to let any more time go by. The first recall I understand was 2015, I was never contacted!
Thank you for your time,
Teresa Clanton
803-329-38216 - hm
803-448-2402 - cell
Class 1 Device Recall ReSTOR IOL
see related information
Date Initiated by FDA Date Posted August 07, 2015
Recall Status1
Open3, Classified
Recall Number Z-2323-2015
Recall Event ID 71630
Product Classification
intraocular lens - Product Code HQL
Product
ReSTOR intraocular lens and ReSTOR Toric intraocular lens.
The Alcon AcrySof IQ ReSTOR and IQ ReSTOR Toric intraocular lenses are posterior chamber lenses intended as optical implants designed to replace the human crystalline lens in adult patients following cataract surgery. The lenses subject to this correction are manufactured specifically for Japan
Code Information:
Model Numbers: SN6AD1, SN6AD3, SV25T0, MN6AD1,SND1T3, SND1T4, SND1T5 and SND1T6 and all lot numbers.
Recalling Firm/Manufacturer
Alcon Research, Ltd.
6201 South Fwy
Fort Worth TX 76134-2099
For Additional Information Contact
N/A
800-862-5266
Manufacturer Reason for Recall
There are reports of post - operative inflammation and/or toxic anterior segment syndrome (TASS) after cataract surgery.
FDA Determined
Cause 2 Process design
Action - Alcon Research sent recall notification letters dated April 16, 2015, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to stop using the affected product and place on hold until their sales representatives visit their site for withdrawal. Follow up communication activities included personal contact via phone and site visits. For questions regarding this recall call 817-293-0450.
Quantity in Commerce - 45,391
Distribution - Distribution Japan, No US distribution.
Total Product Life Cycle
TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
Page Last Updated: 05/05/2017
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
you are so right! My life is miserable since Oct. 13, 2012, now a 2015 recall on the lens confirms exactly what I knew... they are defective! I had the ReSTOR Muliti focal Lens procedure, since that day October 13, 2012 I cannot put into words how my life has drastically changed, constant pain, constant vision problems, and the feeling of despair is unbearable. I have researched for years trying to find an answer to my problems. The doctor that did the procedure was no help and seemed not interested and acted insulted. After many years of research, a couple weeks ago I came across an FDA report, the Alcon manufactures makers of the lens have a recall on the exact lens that are in my eye's...model #SN6AD1, I understand Alcon are trying to say the lens with these model numbers were 'all' sent only to Japan and did not effect Americans, but my model number is one of the numbers on recall... I knew something was wrong all these years!
I presented the proof of recall to the doctor that did the procedure in 2012 and he is now giving me attention for my concerns. I had a procedure free of charge by him April 27, 2017 that is suppose to help with dry eye's and improve my problem but my eye's are getting worse... it was no help at all! What I am dealing with, I feel is beyond dry eye's! I am actually scared I am going to eventually be blind. I live everyday in misery, the problem with my eye's even clouds my mind... I feel like I am in a fog and cannot think clear! The ReSTOR Mulit focal lens in question are on file with the FDA, the recall is number Z-2323-2015, I found this on my own, my eye doctor acted like he knew nothing about the recall! I understand the FDA require Alcon Laboratories makers of the lens to notify the doctors that used these model numbers? I have read hundreds of comments about people dealing with the same issues as I!
From the day after the procedure my life drastically changed, and continually getting worse! I understand from some people getting second opinions that wanted the lens removed, if a patient for ReSTOR multifocal lens had the YAG (laser polishes the lens) procedure done after the ReSTOR procedure.... it seals the deal and any attempt to have them removed is a 50/50 chance it can result in blindness!
The ReSTOR procedure was for eliminating reading glasses, it has 3 levels close-up, far, and medium vision. Close up was my only problem! It has ruined the quality of my life and sure thousands of others that had the procedure are ruined as well! I still see halos around lights, my eye's ache constantly, both eye's vision is like there is a film of Vaseline across them they are never clear, feel like and like someone blew dust in my eye's, never clear and have a constant nagging pain! Constantly putting drops and gel in my eye's for relief, it only helps for as long as they are in my eye's! To let you know how my eye's feel 1) after you have been in a heavily chlorinated pool have the same feeling constantly. 2) Dust has been blown in my eye's 3) I cannot be on the computer more than 30 minutes at a time, my husband has to finish filling out forms and complete anything I am engaged in! 3) Trying to find a job, my eye problems hindered me from getting the jobs I applied for, the florescent lights and most all jobs require computer... I am limited how long I can look at a computer screen! I have to put my head back, close my eye's to rest them through out the day 4) I cannot wait to go to sleep it is the only relief I get when my eye's are shut or sitting in a dim room! 5) I can only be in stores for a very short while then the glare of the florescent lights increase the pain, can no longer read shelf tags! 6) I have to wear tinted safety glasses all day in-order to function defeating the purpose for me having the ReSTOR Multi focal lens procedure originally! Thought I was getting rid of my cheaters, and be done with glasses forever...what a major mistake! What I would do to get my God given lens back!
I would appreciate your advise on this issue... should I call Alcon Manufactures makers of the ReSTOR lens or should I get a lawyer involved? Alcon Laboratories making the comment about "the lens recalled were those that went to Japan" sounds like they are trying to cover themselves in the US... my lens model number was on the recall, I feel like I am going to get the run around! Quantity in Commerce - 45,391 I feel sure my lens are part of the recall and do not need to let any more time go by. The first recall I understand was 2015, I was never contacted!
Thank you for your time,
Teresa Clanton
803-329-38216 - hm
803-448-2402 - cell
Class 1 Device Recall ReSTOR IOL
see related information
Date Initiated by FDA Date Posted August 07, 2015
Recall Status1
Open3, Classified
Recall Number Z-2323-2015
Recall Event ID 71630
Product Classification
intraocular lens - Product Code HQL
Product
ReSTOR intraocular lens and ReSTOR Toric intraocular lens.
The Alcon AcrySof IQ ReSTOR and IQ ReSTOR Toric intraocular lenses are posterior chamber lenses intended as optical implants designed to replace the human crystalline lens in adult patients following cataract surgery. The lenses subject to this correction are manufactured specifically for Japan
Code Information:
Model Numbers: SN6AD1, SN6AD3, SV25T0, MN6AD1,SND1T3, SND1T4, SND1T5 and SND1T6 and all lot numbers.
Recalling Firm/Manufacturer
Alcon Research, Ltd.
6201 South Fwy
Fort Worth TX 76134-2099
For Additional Information Contact
N/A
800-862-5266
Manufacturer Reason for Recall
There are reports of post - operative inflammation and/or toxic anterior segment syndrome (TASS) after cataract surgery.
FDA Determined
Cause 2 Process design
Action - Alcon Research sent recall notification letters dated April 16, 2015, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to stop using the affected product and place on hold until their sales representatives visit their site for withdrawal. Follow up communication activities included personal contact via phone and site visits. For questions regarding this recall call 817-293-0450.
Quantity in Commerce - 45,391
Distribution - Distribution Japan, No US distribution.
Total Product Life Cycle
TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
Page Last Updated: 05/05/2017
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
I have the same concerns --- right eye nov 15 2017 --- left eye nov 29 2017 --- I am terrified --- I have something in left eye ---What is it ? Dr. says maybe nick from hold-open-clamps Dr says will use YAG laser in May --- I don"t now --- Should I ?
=
711220 tn?1251891127
MEDICAL PROFESSIONAL
I have not heard about it.

Dr. O.
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