AMO Total Care (1) Contact Lens Solution, Formula: 8772x; Product Code: 90275 (240 ml). Relieves the dryness, irritation

FDA device recall Z-0130-2011 · posted 2010-11-02 · Terminated

Recall details

Recalling firm

Abbott Medical Optics Inc (AMO)

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 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.

Root cause

Pending

Status

Terminated

Product code

LPN

Quantity affected

144 units

Distribution

International Distribution Only -- United Kingdom, Lebanon, Dubai, Bahrain, Russia, Kazakhstan, Ireland, and France.

Date initiated

2010-07-23

Date posted

2010-11-02

Date terminated

2011-10-13

Location

Santa Ana, CA