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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-0093-06
Recall Event ID 33849
PMA Number P990080 
Product Classification Intraocular Lens - Product Code HQL
Product Tecnis Monofocal Silicone Posterior Chamber IOLs (Models: Z9000 and Z9001)
Code Information Tecnis¿ Silicone Z9000, 94 lenses   Tecnis Mono 12mm Z9000+11,5 8160800508 Tecnis Mono 12mm Z9000+23,0 8014050508 Tecnis Mono 12mm Z9000+12,0 8110100508 8014060508  8110110508 8014070508 Tecnis Mono 12mm Z9000+20,5 8095430509 8014090508 Tecnis Mono 12mm Z9000+21,0 8062320509 8014100508 Tecnis Mono 12mm Z9000+22,0 8094140509 8014110508  8094150509 8014120508 Tecnis Mono 12mm Z9000+22,5 8080300509 8014130508  8080310509 8014140508  8117480508 8014150508 Tecnis Mono 12mm Z9000+23,0 8012330508 8014160508  8012340508 8014190508  8012360508  Tecnis Mono 12mm Z9000+23,5 8160360508  8012370508  Tecnis Mono 12mm Z9000+24,0 8166940508  8012380508 8166960508  8012400508 8166970508  8012410508   8012430508   8012440508   8012450508   8012460508   8012470508   8012480508   8012510508   8012530508   8012540508   8013910508   8013920508   8013930508   8013940508   8013950508   8013960508   8013970508   8013980508   8013990508   8014000508   8014010508   8014020508   8014030508   8014040508  Tecnis Mono 12mm Z9000+24,5 8037770508  8037780508  8037790508  8037800508  8037810508  8037820508  8037830508  8037840508  8037850508  8037860508  8037870508  8037880508  8037890508  8037900508  8037910508  8037920508  8037930508  8037940508  8037950508  8037960508  8037970508  8037980508  8037990508  8163880508  8163890508  8163900508  8163910508  8163920508  8163930508  8163940508  8163950508  8163960508  8163970508  8163980508  8163990508  8164000508  8164010508  8164020508   Tecnis¿ Silicone Z9001, 13 lenses  Tecnis Mono 13mm Z9001+22.5 8030920508  8030930508  8031100508  8031110508  8031130508  8031140508  8031150508 Tecnis Mono 13mm Z9001+25,5 8111960508  8111970508  8111980508  8111990508  8112000508  8112020508 
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 107 (39 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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