Medical Device Recall: Z-0129-2011

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-0129-2011.

Recall Res Number
Z-0129-2011
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
34,080 units
Product Description 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.
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: AH01202, AH01072, AH01223, AH01224, and AH01225.

Related Establishments / Registrations

Public Record Disclaimer

This page represents an index of public-record FDA device recalls. It does not imply current safety or compliance status of the product. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Refer to official government sources for primary safety alerts.

Account Required Full available specs will require a free AvaSpecs account.