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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 Device Recall AMO Tecnis Acrylic Model ZA9003 Intraocular Lenses see related information
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
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
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
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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