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.
Recall
- Recall Number
- Z-0129-2011
- Event Number
- 56735
- Firm
- Abbott Medical Optics Inc (AMO)
- FEI Number
- 3003843509
- Product Code
- LPN
- Status
- Terminated
- Root Cause
- Pending
- Initiated
- July 23, 2010
- Posted
- November 2, 2010
- Terminated
- October 13, 2011
- Address
- 1700 E Saint Andrew Pl, Santa Ana, CA, 92705
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.
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.
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.
International Distribution Only -- United Kingdom, Lebanon, Dubai, Bahrain, Russia, Kazakhstan, Ireland, and France.
34,080 units