| Class 2 Device Recall AMO Tecnis Acrylic Model ZA9003 Intraocular Lenses | |
Date Initiated by Firm | November 29, 2006 |
Date Posted | December 14, 2006 |
Recall Status1 |
Terminated 3 on May 24, 2011 |
Recall Number | Z-0148-2007 |
Recall Event ID |
36943 |
PMA Number | P990080/S6 |
Product Classification |
Intraocular Lens - Product Code HQL
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Product | AMO Tecnis Acrylic Model ZA9003 Intraocular Lenses |
Code Information |
Serial numbers: 531644065, 5316450605, 5316460605, 5316470605, 5316490605, 5316500605, and 5316510605 |
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 | John Smith 714-247-8691 |
Manufacturer Reason for Recall | The lenses are incorrectly labeled as 11 diopter lenses; these lenses are actually 22.5 diopters. |
FDA Determined Cause 2 | Other |
Action | On November 13, 2006, an 'URGENT MEDICAL DEVICE RECALL' letter was mailed to all affected US customers communicating their recall strategy regarding the removal of five (5) ZA9003 lenses in US distribution. This letter included in this correspondence is a listing of the serial numbers and the quantities of intraocular lenses shipped.
This listing will act as your Facsimile Form to be returned to AMO for accountability of the lenses shipped to your facility. AMO will ensure the effectiveness of the recall by using a return facsimile form to capture the status of each of the lenses. |
Quantity in Commerce | 10 lenses |
Distribution | Worldwide, including USA (CT, TX, NY), Canada, and UK. |
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
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