Medical Device Recall: Z-0130-2011

FDA Recalls dataset · Firm: Abbott Medical Optics Inc (AMO) · Status: Terminated

Recall Action Class: N/A Date Initiated: 2010-07-23 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0130-2011.

Recall Res Number
Z-0130-2011
Recalling Firm / Manufacturer
Abbott Medical Optics Inc (AMO)
FEI Number
3003843509
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2010-07-23
Date Posted
2010-11-02
Date Terminated
2011-10-13
Product Code
LPN
Event Number
56735
Product Quantity
144 units
Product Description AMO 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.
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.
Action Details 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.
Distribution Pattern International Distribution Only -- United Kingdom, Lebanon, Dubai, Bahrain, Russia, Kazakhstan, Ireland, and France.
Code Information / Serial Numbers Lot Numbers: AH01257.

Related Establishments / Registrations

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