FDA Medical Device Recalls (openFDA)
Advanced Medical Optics, Inc.: COMPLETE Multi-Purpose Solution (Asia Pacific markets, excluding Japan, Korea and Thailand), COMPLETE 10 Minute (Japan only), Comfort 8 in 1 Solution (Indonesia only), COMPLETE Comfort Plus All in One Solution (Korea only) & COMPLETE Protec Formula Multi-Purpose Solution (Thailand only)
- Recall number
- Z-0346-2007
- Recalling firm
- Advanced Medical Optics, Inc.
- Product
- COMPLETE Multi-Purpose Solution (Asia Pacific markets, excluding Japan, Korea and Thailand), COMPLETE 10 Minute (Japan only), Comfort 8 in 1 Solution (Indonesia only), COMPLETE Comfort Plus All in One Solution (Korea only) & COMPLETE Protec Formula Multi-Purpose Solution (Thailand only)
- Status
- Terminated
- Initiated
- 2006-09-15
- Posted
- 2007-03-01
- Terminated
- 2010-02-17
- Reason
- 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.
- Root cause
- Other
- Action
- 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.
- Quantity
- 182,678 units for all US products, 2,943,207 units worldwide
- Distribution
- Worldwide including USA, Australia, China, Hong Kong, India, Indonesia, Japan, Korea, Malaysia, New Zealand, Philippines, Singapore, Sri Lanka, Taiwan and Thailand.
- Lot, serial or model codes
- No US distribution
- 510(k) numbers
- ["K981168"]
- PMA numbers
- not on file
- Product code
- LPN
- Firm FEI
- 3003843509
- Firm city
- Santa Ana
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28