Aa
Explant an IOL?
I had a ReStor lens placed in 2008. It has been nothing but trouble and getting worse and worse. I have visited so many surgeons. All say that the risk after YAG is too great. But the side effects are gradually ruining my life—no night driving, no driving in the rain, no close up vision, halos bigger than cars—the usual. I have no other problems with my eyes (retina, cornea, etc).
Is there somebody out there who can help me? Every doctor says, “Not me, try the doctor down the street and gives me a name.” These are very experienced, qualified surgeons. Today’s doctor says, “Think long term…” I AM thinking long term –this cannot go on. Maybe I am too low key. Do I need to say, “Never mind any risks, and just get this out of my eye?”
Thank you everyone in advance, Aleif
Is there somebody out there who can help me? Every doctor says, “Not me, try the doctor down the street and gives me a name.” These are very experienced, qualified surgeons. Today’s doctor says, “Think long term…” I AM thinking long term –this cannot go on. Maybe I am too low key. Do I need to say, “Never mind any risks, and just get this out of my eye?”
Thank you everyone in advance, Aleif
I had 6.5 hours worth of eye surgery at the Univ. of Md. Research Ctr. Eye Clinic, AFTER a Retina "Specialist" in Fairfax Virginia (FFx. Hosp.) stated, "You'll Never see again", &,, HE was SUPPOSED to be "The Best". My original vision before Retina detachment was 2800/20 in That eye. After all was said and done, 25/20 with scare tissue at the optical nerve side of the Retina. On Dec. 11,2002 Dr. Tunis in Wilmington NC did a Intraoclar lens transplant (IOL) with GREAT Success. Also, since my "other" eye's vision was 3200/20 & Peoples' brains Cannot function with THAT kind of corrected vision difference Outside the eye, they corrected vision (& astigmatism) in the "good" eye too. Whoever/whatever has or had been done, in MY opinion, needed a Learning Lesson!!!! I will say this, I had some head trauma recently & the lens in my Operated eye has slipped out of place. Haven't gotten it fixed Yet as it was Yesterday, & I am 400 miles from Dr. Tunis. YEP these people who say call around, check others out... Yep, you've got to do your research & when you see someone, as you learn about it all, YOU can tell who knows what & who is full of $$$BS !!!!!
I think that if you don't have the attributes Jodie mentions, you may need to put up with the necessary steps to correct them. As examples: one might have to go through one or more instances of limbal relaxing incisions, get LASIK iif needed, get a decentered lens recentered if meeded. etc. etc.
Many posters here have articulated various woes with multifocal lenses. I really don't believe these lenses themselves are necessarily problematic. I do believe, however, that it takes a skilled eye surgeon experienced with the type of lens being considered, and I also believe that patients have to understand that corrective procedures may very well be needed after implantation.
Many posters here have articulated various woes with multifocal lenses. I really don't believe these lenses themselves are necessarily problematic. I do believe, however, that it takes a skilled eye surgeon experienced with the type of lens being considered, and I also believe that patients have to understand that corrective procedures may very well be needed after implantation.
I just watched an online video available at today's osnsupersite ("Evaluating unhappy IOL patients with wavefront aberrometry" by David F. Chang, M.D.) The presenter discusses 4 cases of unhappy multifocal patients who became much happier after their multifocal IOL was explanted and replaced with a monofocal lens. (One case was post-YAG, but apparently the explant procedure was still not a big deal.) After analyzing the wavefront data of these patients, the presenter concludes that in addition to a healthy eye, a multifocal IOL requires a perfect cornea and perfect centration. So it makes sense that so many people are unhappy with their multifocals.
Get one of the local docs whom you've already seen to make the appointment for you. You paid them good money for their consultations. I really don't believe that they would have referred their spouse/mother/best friend with your problems to the doctor down the street. You will be seen several weeks (or several months) sooner if you are referred by an another ophthalmologist.
I found the forum after I had the Restor implanted. If I had checked it out first I would never have the had the Restor implanted in the first place either! Good luck to you. Keep us informed.
Thank you for your replies. So true that you can't go back in time. But the lens keeps on driving me crazy. I will contact these doctors and ask them. This forum is a life saver! If I had checked here first, I would certainly not have had ReStor. I will get in touch with these doctors. Thanks again, Aleif
I am the person JodieJ was telling you about who had surgery done by Dr. Robert Bailey in Philadelphia. If it were not for lots of help and great advice from JodieJ and disappointed66 and others on this forum, I don't know what would have happened to me.
JodieJ told me to go find a REALLY good surgeon no matter where I had to travel. All of the local surgeons here told me there was NOTHING that could be done for me and no surgery could possibly fix my eye.
When I had one of my Restor lenses explanted, the local surgeon swore he could do a great job. The surgery went south because he had problems getting the lens out. Ended up completely botching the surgery and implanting the new lens into my eye in such a way that it was rubbing and chafing my iris. The eye became a nightmare.
When other doctors examined the eye they told me "no way to remedy this". jodieJ told me that some doctors tell you that when they don't have the skills to do it.
She also told me to get away from the local doctors. The closest big eye hospital from where I live was Philadelphia...Wills Eye Hospital and that's where I found my wonderful Doctor Bailey who is the head of cataract surgery there. He is not only a great surgeon, but he also is kind and listens to what you are telling him. He was able to do the surgery to repair my lens position which stopped the constant inflammation and pain I had in my eye.
I was able to come off of the prednisone I had been on for ten months.
Can't go back in time, but had I gone there in the first place to have my explant, none of this would have ever happened. If you do this you will save yourself immeasurable grief.
I was not lucky enough to find this website in time before having my explant; but am so grateful to these people for helping me in the end. They really have been through so much themselves that they know what they're talking about and know what we are going through.
Take care
JodieJ told me to go find a REALLY good surgeon no matter where I had to travel. All of the local surgeons here told me there was NOTHING that could be done for me and no surgery could possibly fix my eye.
When I had one of my Restor lenses explanted, the local surgeon swore he could do a great job. The surgery went south because he had problems getting the lens out. Ended up completely botching the surgery and implanting the new lens into my eye in such a way that it was rubbing and chafing my iris. The eye became a nightmare.
When other doctors examined the eye they told me "no way to remedy this". jodieJ told me that some doctors tell you that when they don't have the skills to do it.
She also told me to get away from the local doctors. The closest big eye hospital from where I live was Philadelphia...Wills Eye Hospital and that's where I found my wonderful Doctor Bailey who is the head of cataract surgery there. He is not only a great surgeon, but he also is kind and listens to what you are telling him. He was able to do the surgery to repair my lens position which stopped the constant inflammation and pain I had in my eye.
I was able to come off of the prednisone I had been on for ten months.
Can't go back in time, but had I gone there in the first place to have my explant, none of this would have ever happened. If you do this you will save yourself immeasurable grief.
I was not lucky enough to find this website in time before having my explant; but am so grateful to these people for helping me in the end. They really have been through so much themselves that they know what they're talking about and know what we are going through.
Take care
BTW, I've read posts on this forum about IOLs that were successfully explanted after a YAG. But this undoubtedly takes special skills.
from disappointed66 and restorweary
You may want to get in touch with Dr, Richard Mackool in Astoria Queens, New York. 718 728 3400. He is an expert with Restor lenses.who helped both of us and steered us in the right direction.
We both had the lenses explanted. We agree with jodiej about Dr. Bailey for surgery. His phone number is 215 836-1290.
You may want to get in touch with Dr, Richard Mackool in Astoria Queens, New York. 718 728 3400. He is an expert with Restor lenses.who helped both of us and steered us in the right direction.
We both had the lenses explanted. We agree with jodiej about Dr. Bailey for surgery. His phone number is 215 836-1290.
4 Comments
To mortified to even consider extracted, as miserable as I am I can see I am to scared to risk the chance it could blind me!
It's a good suggestion if you are near to New York. If closer to cincinnati Robert Osher, MD In texas Doug Koch MD
Who can afford to travel and go see an expert, That is why I wanted restitution for this failed ReSTOR lens from the Alcon manufacture in order to pay for professional help! I had the identical number SN6AD1 on the recall list and claimed it was a shipment that went to Japan? i know something is wrong with these lens and are defective in someway because what they are doing to me since the day of the procedure Oct. 2012! My doctor was a reputable surgeon that taught other eye doctors procedures. He told me he was not notified of a recall by Alcon and Alcon was suppose to notify all eye doctors? My doctor has since closed his practice due to sexual harassment charges, non-related to eye's.
Class 1 Device Recall ReSTOR IOL
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Class 1 Device Recall ReSTOR IOL see related information
Date Initiated by Firm April 15, 2015
Date Posted August 07, 2015
Recall Status1 Terminated 3 on June 30, 2017
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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Class 1 Device Recall ReSTOR IOL
Print Share E-mail
FDA HomeMedical DevicesDatabases
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
New Search Back to Search Results
Class 1 Device Recall ReSTOR IOL see related information
Date Initiated by Firm April 15, 2015
Date Posted August 07, 2015
Recall Status1 Terminated 3 on June 30, 2017
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
Page Last Updated: 12/29/2018
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English
Accessibility Contact FDA Careers FDA Basics FOIA No FEAR Act Site Map Nondiscrimination Website Policies
FDA
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10903 New Hampshire Avenue
Silver Spring, MD 20993
Ph. 1-888-INFO-FDA (1-888-463-6332)
Contact FDA
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For GovernmentFor Press
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FDA Archive
U.S. Department of Health & Human Services
You need to see the best of the best cataract surgeons. I don't think that staying local should be your priority. Dr. Robert Bailey at the Wills Eye Hospital in Philadelphia successfully performed a very delicate IOL procedure on one of my friends, and she was extremely pleased with the results. I would trust this surgeon. Alternatively, I'm sure that the Wilmer Eye Institute in Baltimore has excellent senior staff who specialize in explanting IOLs.
You might want to try getting additional referrals from doctors whom you consulted previously. This time let them know that you want to see the best of the best, possibly at Wills Eye Hospital or Wilmer Eye Institute. Ask them who they would recommend for their spouse/mother/best friend who had problems similar to yours. See if they will set up an appointment for you. Another ophthalmologist can get you a MUCH sooner appointment than you could if you called yourself. And some of the top specialists won't even see you without another doctor's referral.
Don't give up hope. I really believe that a very skilled specialist can help you.
You might want to try getting additional referrals from doctors whom you consulted previously. This time let them know that you want to see the best of the best, possibly at Wills Eye Hospital or Wilmer Eye Institute. Ask them who they would recommend for their spouse/mother/best friend who had problems similar to yours. See if they will set up an appointment for you. Another ophthalmologist can get you a MUCH sooner appointment than you could if you called yourself. And some of the top specialists won't even see you without another doctor's referral.
Don't give up hope. I really believe that a very skilled specialist can help you.
MEDICAL PROFESSIONAL
Try to find a surgeon experience in Restor. Look at the Alcon website for Restor and see some doctor listed on the site in your area.
Dr. O.
Dr. O.
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