Recall Z-0539-04 ยท HQL Intraocular Lens
Staar Surgical Co Inc
Collamer UV One-Piece IntraOcular Lens. Models 4205BF and 4204BF
| Date | Feb 18, 2004 (initiated Feb 9, 2004) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.