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U.S. Department of Health and Human Services

Class 2 Device Recall COMPLETE MultiPurpose Solution

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 Class 2 Recall
COMPLETE MultiPurpose Solution
see related information
Date Posted November 02, 2010
Recall Status1 Terminated on October 13, 2011
Recall Number Z-0129-2011
Recall Event ID 56735
Premarket Notification
510(K) Number
K014202 
Product Classification Accessories, Soft Lens Products - Product Code LPN
Product AMO COMPLETE Multi-Purpose Solution, Formula: 9424x; Product Code: 93504 (360ml), 93505 (2x 360ml duo pack), 93515 (240 ml). Cleans, rinses, disinfects, and stores all soft contact lenses and helps keep your eyes protected from dryness and irritation throughout the day.
Code Information Lot Numbers: AH01202, AH01072, AH01223, AH01224, and AH01225.
Recalling Firm/
Manufacturer
Abbott Medical Optics Inc (AMO)
1700 E Saint Andrew Pl
Santa Ana, California 92705
Manufacturer Reason
for Recall
The recall was initiated after AMO determined, through internal testing, that a limited number of the flip top caps used during production of these solutions may leak and, although unlikely, the sterility of the product may be compromised. Products that are non-sterile have the potential to cause eye infections, which may be sight threatening.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action AMO prepared and issued on July 28, 2010 both a customer and distributor notification letter as part of their customer communication process. The letter informed the customers of the reason for recall, the products involved, the hazard involved and actions to be taken regarding the affected products. Customer with questions related to the COMPLETE Multi-Purpose Solution and/or Total Care (1) Contact Lens Solution return process, were instructed to contact an AMO Customer Service Representative at 1800 931 663.
Quantity in Commerce 34,080 units
Distribution International Distribution Only -- United Kingdom, Lebanon, Dubai, Bahrain, Russia, Kazakhstan, Ireland, and France.
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.
510(K) Database 510(K)s with Product Code = LPN and Original Applicant = ALLERGAN, INC.
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