FDA Medical Device Recalls (openFDA)
Advanced Medical Optics, Inc.: CLARIS Cleaning and Soaking Solution, 4 fl. oz.
- Recall number
- Z-0987-05
- Recalling firm
- Advanced Medical Optics, Inc.
- Product
- CLARIS Cleaning and Soaking Solution, 4 fl. oz.
- Status
- Terminated
- Initiated
- 2005-06-13
- Posted
- 2005-07-13
- Terminated
- 2010-02-17
- Reason
- Component mix-up of caps/tips. Absence of red tip indicates improperly that the solution is safe for application to the eye.
- Root cause
- Other
- Action
- Firm intiated recall to distributors on June 13, 2005 by letter.
- Quantity
- 32,916
- Distribution
- Undetermined, assumed to be nationwide thru secondary distributors.
- Lot, serial or model codes
- Lot numbers: AA00785; AA00786: AA01050; AA01076
- 510(k) numbers
- not on file
- PMA numbers
- ["P870023"]
- 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