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Class 2 Device Recall |
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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
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Product |
CeeOn EDGE Silicone Posterior Chamber IOLs (Modelsl 911A and 913A)
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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
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For Additional Information Contact |
Sandra F. Selvaggi 714-247-8656
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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.
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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
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Total Product Life Cycle |
TPLC Device Report
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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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PMA Database |
PMAs with Product Code = HQL and Original Applicant = Johnson & Johnson Surgical Vision, Inc.
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