Advanced Medical Optics, Inc. 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Advanced Medical Optics, Inc.
Lot Codes / Batch Numbers
Z = Hangzhou, China, A = Alcobendas, Spain. The second digit denotes the year of manufacture (A= 2005, B = 2006, 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.
Products Sold
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.
Advanced Medical Optics, Inc. is recalling COMPLETE Amino Moist Multi-Purpose Solution (JAPAN only brand), Formula 9451X, Product Numbers:93323 due to In response to information received 05/25/2007 from the U.S. Centers for Disease Control and Prevention (CDC) regarding eye infections from Acanthamoe. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026