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U.S. Department of Health and Human Services

Class 2 Device Recall AMO Tecnis Acrylic Model ZA9003 Intraocular Lenses

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 Class 2 Recall
AMO Tecnis Acrylic Model ZA9003 Intraocular Lenses
see related information
Date Posted December 14, 2006
Recall Status1 Open
Recall Number Z-0148-2007
Recall Event ID 36943
Premarket Approval
PMA Number
P990080/S006
Product Classification Intraocular Lens - Product Code HQL
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, California 92705-4933
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
PRODUCTION CONTROLS: Labeling Mix-Ups
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

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = HQL and Applicant = ADVANCED MEDICAL OPTICS, INC.
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