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U.S. Department of Health and Human Services

Class 1 Device Recall COMPLETE Amino Moist MultiPurpose Solution

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 Class 1 Recall
COMPLETE Amino Moist MultiPurpose Solution
see related information
Date Posted July 19, 2007
Recall Status1 Open
Recall Number Z-1093-2007
Recall Event ID 38019
Product Classification Accessories, Soft Lens Products - Product Code LPN
Product COMPLETE Amino Moist Multi-Purpose Solution (JAPAN only brand), Formula 9451X, Product Numbers:93323JA, 93324JA, 93325JA, 93326JA, 93327JA, 93328JA, 93329JA, 93330JA, 93331JA, 93332JA, 93333JA, 93334JA, 93335JA, 93336JA & 93337JA
Code Information All Lots (154 lots in Japan). Each product is clearly identified with a lot number and expiration date, which is displayed on either the outer top or bottom panel of the unit carton and on two case labels on the case shipper. In addition, each bottle is clearly identified with a lot number and expiration date. The first digit of the lot number denotes the identification of the AMO manufacturing site, Z = Hangzhou, China, A = Alcobendas, Spain. The second digit denotes the year of manufacture (A= 2005, B = 2006, C = 2007) per AMO Standard Operating Procedure. The third through the seventh digits denote the sequential number of production orders produced in either the Hangzhou, China or Alcobendas, Spain facility in that year, starting with 00001. Note that several product lines use this lot numbering system in each facility, so the sequential numbering is not unique to any specific product or formulation. As an example, ZB01234, the lot number represents the 1,234th production order initiated in the Hangzhou, China facility in 2006.
Recalling Firm/
Manufacturer
Advanced Medical Optics, Inc.
1700 E Saint Andrew Pl
Santa Ana, California 92705-4933
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Sandra F. Selvaggi
714-247-8656
Manufacturer 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.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Under Investigation by the firm
Action 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.
Quantity in Commerce 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, Malaysia, Pakistan and the Philippines).
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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