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U.S. Department of Health and Human Services

Class 2 Device Recall Total Care (1) Contact Lens Solution

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 Class 2 Device Recall Total Care (1) Contact Lens Solutionsee related information
Date Initiated by FirmJuly 23, 2010
Date PostedNovember 02, 2010
Recall Status1 Terminated 3 on October 13, 2011
Recall NumberZ-0130-2011
Recall Event ID 56735
Product Classification Soft Lens Products Accessories - Product Code LPN
ProductAMO Total Care (1) Contact Lens Solution, Formula: 8772x; Product Code: 90275 (240 ml). Relieves the dryness, irritation, and discomfort that may be associated with contact lens wear.
Code Information Lot Numbers: AH01257.
FEI Number 3003843509
Recalling Firm/
Manufacturer		 Abbott Medical Optics Inc (AMO)
1700 E Saint Andrew Pl
Santa Ana CA 92705
For Additional Information Contact
714-247-8656
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		Pending
ActionAMO 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 Commerce144 units
DistributionInternational Distribution Only -- United Kingdom, Lebanon, Dubai, Bahrain, Russia, Kazakhstan, Ireland, and France.
Total Product Life CycleTPLC 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.
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