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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-0097-06
Recall Event ID 33849
PMA Number P880070 
Product Classification Intraocular Lens - Product Code HQL
Product CeeOn Heparin SurfaceModifie (HSM) PMMA
One-Piece Anterior Chamber IOLs (Model: HSM65)
Code Information CeeOn¿ One-Piece PMMA HSM65, 2 lenses  PMMA HSM HSM65+22,0  8054720508 8054730508 
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 45 (4 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 = ABBOTT MEDICAL OPTICS INC
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