FDA Medical Device Recalls (openFDA)
Staar Surgical Co Inc: Collamer UV One-Piece IntraOcular Lens. Models 4205BF and 4204BF
- Recall number
- Z-0539-04
- Recalling firm
- Staar Surgical Co Inc
- Product
- Collamer UV One-Piece IntraOcular Lens. Models 4205BF and 4204BF
- Status
- Terminated
- Initiated
- 2004-02-09
- Posted
- 2004-02-18
- Terminated
- 2005-01-04
- Reason
- Risk of hyperopic refractive changes.
- Root cause
- Other
- Action
- Firm is distributing letters to physicians suggesting ways to mitigate the observed contracture of the eye tissues after implantation. Letters will be sent 2/9/2004.
- Quantity
- No quantity applies.
- Distribution
- Nationwide and to Australia, Canada, Chile, France, Germany, India, Lebanon, South Africa, Switzerland, United Kingdom.
- Lot, serial or model codes
- No codes apply
- 510(k) numbers
- not on file
- PMA numbers
- ["P990013"]
- Product code
- HQL
- Firm FEI
- 2023826
- Firm city
- Monrovia
- 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