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U.S. Department of Health and Human Services

Class 3 Device Recall

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  Class 3 Device Recall see related information
Date Initiated by Firm June 13, 2005
Date Posted July 13, 2005
Recall Status1 Terminated 3 on February 17, 2010
Recall Number Z-0987-05
Recall Event ID 32514
PMA Number P870023 
Product Classification Accessories, Soft Lens Products - Product Code LPN
Product CLARIS Cleaning and Soaking Solution, 4 fl. oz.
Code Information Lot numbers: AA00785; AA00786: AA01050; AA01076
Recalling Firm/
Advanced Medical Optics, Inc.
1700 E Saint Andrew Pl
Santa Ana CA 92705-4933
For Additional Information Contact Sandra Selvaggi
Manufacturer Reason
for Recall
Component mix-up of caps/tips. Absence of red tip indicates improperly that the solution is safe for application to the eye.
FDA Determined
Cause 2
Action Firm intiated recall to distributors on June 13, 2005 by letter.
Quantity in Commerce 32,916
Distribution Undetermined, assumed to be nationwide thru secondary distributors.
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 = LPN and Original Applicant = ADVANCED MEDICAL OPTICS, INC.