Device Recall COMPLETE MultiPurpose Solution 의 리콜

Recall

56735

Class 2

Z-0129-2011

2010-07-23

2010-11-02

Terminated

United States

2011-10-13

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94408

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.