COMPLETE Amino Moist Multi-Purpose Solution (JAPAN only brand), Formula 9451X, Product Numbers:93323JA, 93324JA, 93325JA

FDA device recall Z-1093-2007 · posted 2007-07-19 · Terminated

Recall details

Recalling firm

Advanced Medical Optics, Inc.

Reason for recall

In response to information received 05/25/2007 from the U.S. Centers for Disease Control and Prevention (CDC) regarding eye infections from Acanthamoeba, a naturally occurring water-borne organism which can contribute to serious corneal infections. CDC estimates a risk of at least seven times greater for those who use Complete MoisturePlus solution versus those who did not.

Action taken

On Friday, May 25, 2007 at 11:16 ET, AMO issued a press release to the market related to the voluntary recall of AMO's COMPLETE MoisturePLUS TM Multi-Purpose Solution from the market. Similar press releases, specific to the geographic regions, were issued in the other markets beginning on Saturday, May 26, 2007. A copy of the United States press release is present on the AMO website (www.amo-inc.com) and was forwarded to the FDA for posting on the FDA web site. In addition, the FDA also completed a press release related to the AMO recall and it is available on the FDA web site. Regulatory agency notifications in all markets affected outside the United States were initiated beginning on Monday, May 28. Beginning on Thursday, May 31, AMO (via Stericycle) distributed RetaiI Customer notification packages via overnight UPS delivery to the 485 customer accounts in the United States.

Root cause

Labeling design

Status

Terminated

Product code

LPN

Quantity affected

3,794,990 units in Japan (57,252,581 Worldwide)

Distribution

Worldwide including USA, Canada, Europe, Japan, China and various Asia Pacific countries (to include Hong Kong, Australia, New Zealand, Korea, Vietnam, Singapore, India, Indonesia, Sri Lanka, Taiwan,

Date initiated

2007-05-25

Date posted

2007-07-19

Date terminated

2012-01-10

Location

Santa Ana, CA