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.
- Company
- Abbott Medical Optics Inc (Amo)
- Recall Initiated
- July 23, 2010
- Posted
- November 2, 2010
- Terminated
- October 13, 2011
- Recall Number
- Z-0129-2011
- Quantity
- 34,080 units
- Firm Location
- Santa Ana, CA
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.
Distribution
International Distribution Only -- United Kingdom, Lebanon, Dubai, Bahrain, Russia, Kazakhstan, Ireland, and France.
Lot / Code Info
Lot Numbers: AH01202, AH01072, AH01223, AH01224, and AH01225.
Root Cause
Pending
Action Taken
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.