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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm October 05, 2005
Date Posted October 28, 2005
Recall Status1 Terminated 3 on May 23, 2008
Recall Number Z-0095-06
Recall Event ID 33849
PMA Number P990080 
Product Classification Intraocular Lens - Product Code HQL
Product CeeOn EDGE Silicone
Posterior Chamber IOLs
(Modelsl 911A and 913A)
Code Information CeeOn¿ EDGE Silicone 911A, 189 lenses  SLMP 911A +10,0 8131520508 SLMP 911A +11,5 8116020508  8116050508  8116060508 SLMP 911A +13,0 8189380508 SLMP 911A +13,5 8108000508 SLMP 911A +14,0 8033720508  8090160508  8224980508 SLMP 911A +15,0 8105650508  8105660508  8105680508  8105690508  8105730508  8105740508  8105760508  8105770508  8105790508 SLMP 911A +15,5 8064660508  8064800508  8186100508  8186110508 SLMP 911A +16,5 8063190508  8063270508  8063280508  8063290508  8063300508  8063310508 SLMP 911A +17,0 8062880508  8062920508  8062960508  8062970508  8062980508  8063000508  8236490508 SLMP 911A +17,5 8047590508  8047830508 SLMP 911A +18,0 8058440508  8058450508  8058460508  8058470508  8058490508  8058500508  8058520508 SLMP 911A +18,5 8058030508  8058110508  8058350508  8058360508  8139110508  8139150508 SLMP 911A +19,5 8047170508  8047180508  8047200508  8047210508  8047220508  8047250508  8047340508  8047360508 SLMP 911A +21,5 8082640508  8082660508  8082670508  8082680508  8082740508  8082750508  8082760508  8082770508  8082780508  8082920508  8084420508  8084670508 SLMP 911A +22,0 8056570509  8056590509  8164620508 SLMP 911A +22,5 8081650508  8081710508  8081770508  8081790508  8081820508  8081830508  8081840508  8081850508  8081860508  8081870508  8108460508  8108470508  8108500508  8108510508  8108520508  8108560508  8108650508  8165340508  8165350508  8165360508  8165370508  8165380508  8165390508  8165400508  8165410508  8165420508  8165430508 SLMP 911A +23,0 8085040508  8085050508  8085060508  8085080508  8085090508  8085100508  8085120508  8085130508  8085140508  8085150508  8085160508  8085170508  8085180508  8085190508  8085220508  8085230508  8086900508  8086910508  8086920508  8086930508  8086940508  8087040508  8087050508  8087060508  8087070508  8087080508  8176340508 SLMP 911A +24,0 8089850508  8089910508  8175230508  8175260508  8194110508  8194120508  8194130508  8194140508  8194160508  8194180508  8194820508  8194910508  8194950508  8195360508  8195370508  8195410508  8195470508  8195520508 SLMP 911A +24,5 8084090508  8084100508  8084200508  8089000508  8168060508 SLMP 911A +25,0 8067040508  8067300508 SLMP 911A +25,5 8084740508  8084770508  8084780508  8084790508  8084940508  8084950508  8092820508 SLMP 911A +26,5 8100530508  8100540508  8100560508  8100640508  8100660508 SLMP 911A +27,0 8099340508  8099380508 SLMP 911A +28,0 8085670508  8085950508  8085960508 SLMP 911A +28,5 8077790508  8077860508  8102970508  8103030508  8103040508  8103080508  8103090508  8103100508  8103120508  8103130508  8103140508 SLMP 911A +29,0 8096860508  8096900508 SLMP 911A +29,5 8095320508  8095330508 SLMP 911A +30,0 8106430508  8106440508  8106450508  8106460508  8106470508  CeeOn¿ EDGE Silicone 913A, 103 lenses   SLMP 913A +11,0 8184650508 SLMP 913A +15,5 8171590508 SLMP 913A +18,5 8177910508  8177920508  8177960508  8177970508  8178040508 SLMP 913A +19,0 8053490508  8053520508  8053530508  8181070508 SLMP 913A +19,5 8052440508  8052460508  8052470508  8052480508  8052680508 SLMP 913A +20,0 8053300508 SLMP 913A +20,5 8245300508  8245310508  8245320508  8245330508  8245340508  8245350508  8245370508  8245420508  8245430508  8245440508  8245450508  8245460508  8245470508  8245540508  8245570508 SLMP 913A +21,0 8179350508  8179360508  8179370508  8179380508  8179390508  8179400508  8179450508  8179460508  8183440508  8183520508  8183540508  8183550508  8183560508  8183570508  8183580508 SLMP 913A +22,0 8035910509  8070510508  8180690508  8180700508  8180710508  8180720508  8180730508  8180740508  8180750508  8180760508  8180770508 SLMP 913A +22,5 8227980508  8227990508  8228000508  8228010508  8228020508  8228050508  8228200508  8228210508  8228220508 SLMP 913A +23,0 8227170508  8227210508  8227220508  8227240508  8227250508  8227260508  8227270508 SLMP 913A +23,5 8077180508  8077230508  8077240508  8077280508  8180250508  8180260508 SLMP 913A +24,0 8176510508  8176520508  8176530508  8176540508  8176550508  8176560508  8176570508  8176580508  8176590508  8176600508  8176610508  8176620508  8181330508  8181380508  8181390508  8181400508 SLMP 913A +24,5 8078360508  8178480508  8178680508  8178690508 SLMP 913A +25,0 8182890508  8182900508  8182930508 
Recalling Firm/
Manufacturer		 Advanced Medical Optics, Inc.
1700 E Saint Andrew Pl
Santa Ana CA 92705-4933
For Additional Information Contact Sandra F. Selvaggi
714-247-8656
Manufacturer Reason
for Recall		 A small opening (channel or tunnel) in the seal of the outer Tyvek pouch which contains the lens case, in which the sealed intraocular lens is packaged may not be adequately sealed, therefore the potentially compromised outer Tyvek pouch may not be sterile and may potentially contaminate an otherwise sterile field during surgery.
FDA Determined
Cause 2		 Other
Action A product notification letter was mailed to all US domestic customers via overnight carrier (Federal Express) beginning on October 5, 2005. A global notification letter will be translated into the local languages by the international AMO affiliates and mailed to international customers as soon as a listing of all customers is tabulated.
Quantity in Commerce 292 (28 in US)
Distribution Nationwide, Austria, Belgium, Switzerland, Germany, Denmark, France, UK, Guadelope, Hong Kong, Croatia, India, Italy, Netherlands, and Vietnam
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.
PMA Database PMAs with Product Code = HQL and Original Applicant = Johnson & Johnson Surgical Vision, Inc.
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