FDA Medical Device Recalls (openFDA)
Bausch & Lomb Surgical, Inc.: SoFlex UV-Absorbing Model LI61U Silicone Posterior Chamber Intraocular Lens.
- Recall number
- Z-1093-04
- Recalling firm
- Bausch & Lomb Surgical, Inc.
- Product
- SoFlex UV-Absorbing Model LI61U Silicone Posterior Chamber Intraocular Lens.
- Status
- Terminated
- Initiated
- 2004-02-27
- Posted
- 2004-07-20
- Terminated
- 2012-05-03
- Reason
- Lens may be labeled with incorrect diopter size.
- Root cause
- Other
- Action
- The firm telephoned direct medical facility consginees on 2/27/2004 instructing to determine the disposition of the lenses and to return unimplanted ones. Follow-up phone calls were made in March 2004 for unresolved consignees.
- Quantity
- 36
- Distribution
- Nationwide & puerto rico. FL, MA, CA, CT, MI, NY, IN, ID, GA, PA, IL, CO, TN, NC, PR, TX, ME and OH.
- Lot, serial or model codes
- 8XRJ
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HQL
- Firm FEI
- 1119279
- Firm city
- Clearwater
- Firm state
- FL
- 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