Collamer UV One-Piece IntraOcular Lens. Models 4205BF and 4204BF
FDA device recall Z-0539-04 · posted 2004-02-18 · Terminated
Recall details
- Recalling firm
- Staar Surgical Co Inc
- Reason for recall
- Risk of hyperopic refractive changes.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- HQL
- Quantity affected
- No quantity applies.
- Distribution
- Nationwide and to Australia, Canada, Chile, France, Germany, India, Lebanon, South Africa, Switzerland, United Kingdom.
- Date initiated
- 2004-02-09
- Date posted
- 2004-02-18
- Date terminated
- 2005-01-04
- Location
- Monrovia, CA
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