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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-0094-06 |
Recall Event ID |
33849 |
Product Classification |
Intraocular Lens - Product Code HQL
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Product |
Tecnis Multifocal Silicone Posterior Chamber IOLs (Model: ZM900) |
Code Information |
Tecnis¿ Silicone ZM900, 7 lenses Tecnis Multi 12mm ZM900+23,0 8027950508 8027960508 8027990508 Tecnis Multi 12mm ZM900+24,0 8026240508 8026260508 8026280508 8026310508 |
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 |
7 (none 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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