Advanced Medical Optics, Inc. Krystal Klear Rinse (China only) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Krystal Klear Rinse (China only)
Brand
Advanced Medical Optics, Inc.
Lot Codes / Batch Numbers
No US distribution
Products Sold
No US distribution
Advanced Medical Optics, Inc. is recalling Krystal Klear Rinse (China only) due to Due to a potential sterility issue with the product container. Three lots sold in Japan were found to have bacterial contamination, which compromised . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to a potential sterility issue with the product container. Three lots sold in Japan were found to have bacterial contamination, which compromised sterility. Because of this production-line issue at the firm's plant in China, AMO is recalling lots that were manufactured on the same production lines during the same production period.
Recommended Action
Per FDA guidance
Beginning on September 15, 2006, a product notification letter was sent via facsimile or communicated via telephone with each of the customer accounts. Beginning on September 19, 2006, an AMO Japan sales representative visited each of the customer accounts obtaining COMPLETE Amino Moist Multi-Purpose Solution subject to recall. Letters dated November 21, 2006 were sent from AMO, Santa Ana, California beginning Novemer 27, 2006.
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