FDA Medical Device Recalls (openFDA)
Bausch & Lomb Inc: Adapt AO, Akreos Advanced Optics Aspheric Lens. Bausch & Lomb Incorporated, Rochester, NY. Manufactured by Bausch & Lomb Incorporated, Clearwater, FL.
- Recall number
- Z-1911-2009
- Recalling firm
- Bausch & Lomb Inc
- Product
- Adapt AO, Akreos Advanced Optics Aspheric Lens. Bausch & Lomb Incorporated, Rochester, NY. Manufactured by Bausch & Lomb Incorporated, Clearwater, FL.
- Status
- Terminated
- Initiated
- 2008-12-08
- Posted
- 2009-09-09
- Terminated
- 2009-11-05
- Reason
- Affected lenses were inadvertently shipped to Bausch & Lomb's European Logistics Center (ELC) prior to release authorization. Initial testing indicated the product did not meet release criteria for endotoxin limits.
- Root cause
- Release of Material/Component prior to receiving test results
- Action
- All consignees were notified via phone, telefax and letter. Products are to be returned to Bausch & Lomb's European Logistics Center (ELC) for destruction. Direct questions to Bausch and Lomb, Inc. by calling 1-585-338-6612.
- Quantity
- 158
- Distribution
- Foreign Distribution only -- Algeria, Belgium, Bulgaria, Croatia, Germany, Hungary, Ireland, Israel, Italy, Mexico, Portugal, Spain, Thailand and United Kingdom.
- Lot, serial or model codes
- Lot Numbers: 1829803, 1829803, 1829814, 1829823 and 1829824.
- 510(k) numbers
- not on file
- PMA numbers
- ["P060022"]
- Product code
- HQL
- Firm FEI
- 1317628
- Firm city
- Rochester
- Firm state
- NY
- 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