Summary of MedSun Reports Describing Problem with Intraocular Lenses
MedSun: Newsletter #67, December 2011

The intraocular lens (IOL) is an artificial lens which is implanted in the eye to restore vision after a clouded natural lens, referred to as a cataract, is removed. The IOL may be placed in either the anterior or posterior chamber of the eye. The implanted IOL corrects the visual impairment of aphakia or absence of the natural lens.

Over the past 2 years, MedSun has received 26 adverse event reports associated with the implantation of IOLs. These reports were received from 15 MedSun sites. The IOL devices identified in the reports were manufactured by Abbott Medical Optics Inc. (AMO), Alcon Research, LTD, Bausch & Lomb Inc , and Hoya Surgical Optics, Inc.
The reports were submitted during the time frame of October 2009 through July 2011.

The reported device problems were:

• 12 reports described a broken Haptic
• 6 reports listed a defective or broken lens
• 5 reports listed a defective Haptic
• 1 report described a lens cartridge deployment issue which resulted in a bent Haptic
• 2 reports listed unknown device issues

The reported patient problems listed were:

• 18 reports involved the use of a second/replacement lens which required additional surgery time
• 1 report stated a second surgery was needed
• 1 report described the need for an additional procedure

Of the reports that listed patient age, the age range was from 24 years through 91 years. Of the reports that listed patient gender, a total of 15 reports involved female patients and a total of 8 reports involved male patients.

The MedSun reports summarized above, in addition to manufacturer, healthcare, and voluntary reports contributed to FDA awareness of the device problems.

The following recalls are associated with intraocular lenses (IOL) since 2009. The MedSun-reported events may, or may not, be involved in the recalls listed.

Recall Number: Z-2802-2011
Date Posted: July 14, 2011
Product: iSert Intraocular Lens (Model PC-60AD)
Code Information: All serial numbers of I-ISO Model FC-60AD & PC-60AD lenses shipped to the U.S. and affected by this recall.
Recalling Firm/Manufacturer: Hoya Surgical Optics, Inc.
Action: Hoya Surgical Optics Inc. sent an "URGENT MEDICAL DEVICE REMOVAL" letter dated June 22, 2011 to all affected customers. The letter identifies the product, problem, and the actions to be taken. The letter instructs customers to quarantine affected product and return to HSO at their earliest convenience. Shipping instructions are included in the letter. Customers are to complete an Effectiveness Check Questionnaire and fax it to 1-909-680-3986. Questions regarding the recall process are directed to Hoya Customer Service at 1-866-750-5870 or e-mail at customercare@hoyasurgopt.com
Distribution: Nationwide Distribution
Online Link: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=101699

Recall Number: Z-2801-2011
Date Posted: July, 14, 2011
Product: iSymm Intraocular Lens (Model FC-60AD)
Code Information: All serial numbers of I-ISO Model FC-60AD & PC-60AD lenses shipped to the U.S. and affected by this recall.
Recalling Firm/Manufacturer: Hoya Surgical Optics, Inc.
Action: Hoya Surgical Optics Inc. sent an "URGENT MEDICAL DEVICE REMOVAL" letter dated June 22, 2011 to all affected customers. The letter identifies the product, problem, and the actions to be taken. The letter instructs customers to quarantine affected product and return to HSO at their earliest convenience. Shipping instructions are included in the letter. Customers are to complete an Effectiveness Check Questionnaire and fax it to 1-909-680-3986. Questions regarding the recall process are directed to Hoya Customer Service at 1-866-750-5870 or e-mail at customercare@hoyasurgopt.com.
Distribution: Nationwide Distribution
Online Link: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=101697

Recall Number: Z-2706-2011
Date Posted: June 29, 2011
Product: Brand Name STAAR Surgical Collamer® Ultraviolet-Absorbing Posterior Chamber
Single Piece Foldable Intraocular Lens Common Names Collamer single piece IOL Collamer plate haptic IOL The Device is intended to correct aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by cataract extraction. The Device is to be implanted in the posterior chamber and in the capsular bag through a tear-free capsulorhexis (circular tear anterior capsulotomy).
Code Information: CC4204BF and CC4204A
Recalling Firm/Manufacturer: Staar Surgical Co.
Action: Staar Surgical send out an URGENT - Medical Device Correction Notice to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to acknowledge receipt of the letter by signing, dating, and faxing the form to Staar Surgical. For any questions call (800) 292-7902, ext 2345.
Distribution: Worldwide Distribution - USA (nationwide) and the countries of South Africa, Slovakia, Mexico, Hong Kong, and Sri Lanka
Online Link: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100868

Recall Number: Z-0605-2010
Date Posted: January 12, 2010
Product: AMO Tecnis 1-Piece Intraocular Lens (Model ZCB00)
Code Information: All serial number of tecnis 1-Piece Intraocular Lenses that were processed through lens surface treatment at the AMO PR facility between May 19 and October 16, 2009-with serial numbers ending in 0906, 0907, 0908, and 0909, and subset with serial numbers ending in 0905 and 0910. Expiration/Use By Date (YYYY-MM). 2011-05, 2011-06, 2011-07, 2011-08, 2011-09, and 2011-10.
Recalling Firm/Manufacturer: Abbott Medical Optics Inc. (AMO)
Action: Beginning on Friday, November 6, 2009, AMO began distribution of the Recall Notification Letter via Federal Express to the 874 AMO Tecnis 1-piece IOL customer accounts in the US. Included with the Recall Notification letter is a facsimile delivery confirmation that each customer was instructed to fax back to AMO to confirm receipt of the Recall Notification Letter. --- Beginning on Monday, November 9, 2009, AMO began distribution of the Recall Notification letter to the AMO Tecnis 1-piece IOL customer/distributors accounts outside the USA. "THIS RECALL NOTIFICATION DOES NOT INVOLVE TECNIS 1-PIECE IOL THAT HAVE BEEN IMPLANTED. ONCE THE HAPTICS HAVE BEEN SUCCESSFULLY DEPLOYED, THESE LENSES FUNCTION PROPERLY." Questions should be directed to an AMO Customer Service Representative at 1-877-AMO4LIFE (1-877-266-4543).
Distribution: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, NC, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY, Hawaii, and Puerto Rico. INTERNATIONAL: Austria, Azerbaijan, Belgium, Canada, Switzerland, Cyprus, Czech Republic, Germany, Estonia, Spain, Finland, France, United Kingdom, Hungary, Ireland, Israel, Italy, Lebanon, Lichtenstein, Libya, Martinique, Netherlands, Poland, Palestine, Portugal, Saudi Arabic, Sweden, Slovenia, Turkey, and South Africa.
Online Link: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86507

Recall Number: Z-0591-2010
Date Posted: January 11, 2010
Product: Bausch & Lomb SoFlex SE Foldable Intraocular Lens. UPC 4001404, Rx Only, STERILE. Manufactured by: Bausch & Lomb Incorporated,
21 Park Place Boulevard, Clearwater, FL 33759. Intraocular lens indicated for primary implantation for visual correction in adult patients where the cataractous lens has been removed by phacoemulsification. The lens is intended for placement in the capsular bag.
Code Information: Model Number: LI61SE, Lot Number 4916928
Recalling Firm/Manufacturer: Bausch & Lomb Inc.
Action: Bausch & Lomb, Inc. notified consignees via phone beginning November 19, 2009 and by follow-up letter dated November 23, 2009. Titled "Urgent - Medical Device Recall", the letter instructed users to discontinue implantation of the affected product and return any unused lenses along with the enclosed acknowledgement form to the firm. For further information, contact Bausch & Lomb at 1-585-338-6612.
Distribution: Lenses were distributed to one distributor and 35 retailers. Worldwide Distribution-Distribution to Canada, Taiwan and throughout the United States.
Online Link: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86910



The following table lists the MedSun reports that are described in the device problem summary above.

Summary of MedSun Reports Describing Problem with Intraocular Lenses
Device Manufacturer and BrandDevice Identifiers (Model Number, Lot Number) Event Description
Alcon Laboratoies, Inc./Acrysof IOL Model #/MA30AC, N/A During a Cataract removal with Intaoccular Lens Implant, Dr. noticed, prior to reaching the patient, that the lens had a crimped haptic. The lens was then set off to the side and a second implant was obtained for use.
Hoya Surgical Optics, Inc./iSert IOL Model #/PC-60AD, N/A During PEM with IOL implant, surgeon inserted a pre-loaded IOL into patient eye and observed haptic was missing from lens. Suregon removed defective lens and completed case without incident using another IOL (same manufacturer, model # and diopter.)
Alcon Laboratoies, Inc./Acrysof IOL Model #/SN60WS, N/A The intraocular lens implant was defective. One of the haptics was too short (half the length that it should have been). ====================== Manufacturer response for intraocular lens implant, acrysof IQ (per site reporter): They stated that they will report it to consumer affairs.
Alcon Laboratoies, Inc./Acrysof IQ IOL Model #/SN60WF, N/A During surgical procedure, surgeon attempted to inject intraocular lens into Right eye using cartridge. Lens appeared to have jammed in cartridge and would not release lens. Another intraocular lens implanted without difficulty.
Alcon Laboratories, Inc./AcrySof IOL Model #/SA60AT, N/A While inserting optic lens it crumbled and had to be removed piece by piece.
Alcon Laboratories, Inc./AcrySof IQ IOL Model #/SN60WF, N/A After surgeon injected newly implanted lens, it was noticed one of the haptics was broken off the lens. Lens explanted and new lens implanted without incident. Manufacturer notified and sale representative to pick up defective lens. ======================Alcon Sales Representative picked up the lens. She spent time in the OR with surgeon and nursing staff. They reviewed techniques for loading cartridge and injection of lens. A faint line near the haptic was noted on occasional lenses. Representative to take this information back to Alcon for investigation.
Alcon Laboratories, Inc./AcrySof IQ IOL Model #/SN60WF, N/A After surgeon injected newly implanted lens, it was noticed one of the haptics was broken off the lens. Lens explanted and new lens implanted without incident. Manufacturer notified and sales representative to pick up defective lens. =====================Alcon Sales Representative picked up the lens. She spent time in the OR with surgeon and nursing staff. They reviewed techniques for loading cartridge and injection of lens. A faint line near the haptic was noted on occasional lenses. Representative to take this information back to Alcon for investigation.
Alcon Laboratories, Inc./AcrySof IQ IOL Model #/SN60WF, N/A "After surgeon injected newly implanted lens, it was noticed one of the haptics was broken off the lens. Lens explanted and new lens implanted without incident. Alcon notified, sales reprentative to pick up defective lens. ====================== Manufacturer response
======================
Alcon Sales Representative picked up the lens. She also spent time in the OR with Surgeon and nursing staff. They reviewed techniques for loading catridge and injection of lens. A faint line near the Haptics was noted on occasional lenses. Manufacturer representative to take this information back to Alcon for investigation"
Alcon Laboratories, Inc./SN60WF IOL Model #/SN60WF, N/A During insertion of Alcon SN60WF intraocular lens, the trailing haptic of the intraocular lens broke intraocularly. This was sucessfully retrieved and the entire lens cut and rotated out of the eye safely.
Alcon Laboratories, Inc./AcrySof IQ IOL Model #/SN60WF, N/A The haptic of the intraocular lens implant broke while being implanted by the surgeon into the right eye of the patient. Surgeon removed the broken lens and replaced it with another similar lens.
Alcon Laboratories, Inc./AcrySof IQ IOL Model #/SN60WF, N/A After surgeon injected newly implanted lens, it was noticed one of the haptics was broken off the lens. Lens explanted and new lens implanted without incidence. Complaint questionaire completed and given to Sales Representative. =======================
Health Professional's Impression
======================
Lens "too" warm and soft with insertion
Alcon Laboratories, Inc./AcrySof IQ IOL Model #/SN60WF, N/A "After surgeon injected newly implanted lens, it was noticed one of the haptics was broken off the lens. Lens explanted and new lens implanted without incidence. Complaint questionnaire completed and given to Sales Representative. ======================
Health Professional's Impression
======================
Lens ""too"" warm and soft with insertion"
Alcon Laboratories, Inc./AcrySof IQ IOL Model #/SN60WF, N/A After surgeon injected newly implanted lens, it was noticed one of the haptics was broken off the lens. Lens explanted and new lens implanted without incidence. ============================================
Alcon Sales represetnative notified by leaving voice mail message. Lens and injector cartridge saved for representative to pick up.
Acon Laboratories, Inc./AcrySof IQ IOL Model #/SN60WF, N/A After surgeon injected newly implanted lens, it was noticed one of the haptics was broken off the lens. Lens explanted and new lens implanted without incidence. ====================== Alcon Sales Representative notified of continued problem with haptic breakage. Rep will be overnighting 2 new lens injectors to try. Rep will pick up explanted lens and cartridge.
Alcon Laboratories, Inc./AcrySof IQ IOL Model #/SN60WF, N/A Lens found to have broken haptic after implantation. Lens explanted and another lens implanted without incidence. ====================== Manufacturer response for Intraocular lens implant, AcrySof IQ IOL 29.5D ======================Alcon Sales Representative notified. After procedure,it was noted that D cartridges usually are used up to +27.00 lenses and C cartridges up to +30 for SN60WF. Rep states numerous other places use D cartridges to inject the higher power lenses without incidence and did not realize the box on D cartridges stated up to +27. Rep to pick up explanted lens and cartridge.
Abbott Medical Optics, Inc./Tecnis IOL Model #/ZA9003, N/A MD noted upon removal from packaging that device was damaged.
Abbott Medical Optics, Inc./Tecnis 1 IOL Model #/ZCB00, N/A Surgeon was flushing IOL prior to implanting lens. Surgeon observed opaque white spot in the lens and rejected it. Surgeon requested another lens - same model and diopter. Second lens was successfully implanted without incident. No adverse patient event. ======================
Health Professional's Impression
======================
Surgeon was flushing IOL prior to implanting IOL; under microscope the surgeon observed a defect in the lens - an opaque white spot. Hence, lens could not be implanted.
Bausch & Lomb, Inc./SofPort Aspheric IOL Model #/PC-L161AO, Lot #/4015506 During lens insertion of an elderly patient undergoing right eye cataract extraction with lens implant and vitrectomy in Ambulatory Surgery setting, the implant broke and surgeon replaced with new lens. The surgeon inspected the eye and completed the procedure.
Alcon Laboratories, Inc./AcrySof IOL Model #/SA60AT, N/A Before implantation, IOL haptic was seen as bent.
Abbott Medical Optics, Inc./Tecnis IOL Model #/ZA9003, N/A Patient received right lens implant early this year. No problems with surgery or follow-up care. Approximately two months later, the patient was diagnosed with pneumonia and given antibiotics at a clinic. Within 6 hours of taking meds, face began to swell. Came to our ER 5 days later, and was diagnosed with necrotizing fasciitis. Was taken to the OR four consecutive days for debridement of parapharyngeal space, right lip, face and parotid area. Cultures grew MRSA. Septic shock - treatment with vano, zosyn, clindamycin and fluconazole. Patient died on the fourth day.

======================
Health Professional's Impression
======================
MD unsure if this event had anything to do with the corneal lens implant from 2 months prior.
Alcon Laboratories, Inc./AcrySof IOL Model #/MA50BM, N/A Patient scheduled today for repositioning of the IOL. Doctor removed the IOL due to a broken haptic. The implant was freely mobile although it was well centered. When it was moved to the side it was apparent that the inferior haptic had broken off of the implant and that was the reason for the dislocation. When the iris was retracted inferotemporally the haptic was visible.
Abbott Medical Optics, Inc./Tecnis IOL Model #/ZA9003, N/A Lens was opened, as tech started to fold the lens, it appeared not to fold the correct way. The lens appeared to fold upward instead of down. Tech felt that if the lens was forced to fold correctly it would have broken, so the surgeon requested another lens be opened and used. This lens did not contact the patient and the second lens was used to complete the procedure. Manufacturer provided RGA for product return evaluation.
Bausch & Lomb, Inc./SofPort AO with Violet ShieldL Model #/L161AOV, N/A
Model #/L161AOV , N/A
Model #/EZ-28, Lot #/H710801
Model #/Ez-28, Lot #/H820301
The Bausch & Lomb lens injector was not functioning properly. It bent the haptics on the lenses. Physician tried two different lenses and two different injectors. Physician feels it may have been a bad lot. Problem identified prior to any patient contact. Manufacturer response (as per reporter) for Advanced Optics Aspheric Lens, SofPort AO with Violet Shield;

Manufacturer provided RGA# for product return evaluation.

Manufacturer response (as per reporter) for Lens Injector, (brand not provided;

Manufacturer provided RGA# for product return evaluation.
Alcon Laboratories, Inc./AcrySof IOL Model #/MA50BM, N/A After surgeon placed IOL in pt's eye, the haptic broke off. Haptic retrieved and both haptic and lens removed. Surgeon reported no harm to patient. Manufacturer response (as per reporter) for Intraocular Lens, (brand not provided: Taken for review.
Alcon Laboratories, Inc./AcrySof IQ IOL Model #/SN6AT4, N/A Intraocular lens was implanted into the left eye. Upon insertion, lens was noted to have dots/pitting along center of lens. Incision was extended and lens cutter was used to cut the lens and remove. A new lens was inserted and the incision was closed with suture. Proper procedure and instruments were used to load the lens.
Alcon Laboratories, Inc./AcrySof IOL Model #/SA60, N/A The lens was placed in the pt's right eye by the MD. After placing the lens, the MD noticed that the lens was cracked. The lens was removed and replaced.


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