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Terminated

Collamer UV One-Piece IntraOcular Lens. Models 4205BF and 4204BF

FDA Recall Z-0539-04 · Posted 2004-02-18

Recalling FirmStaar Surgical Co Inc
Recall StatusTerminated
Product CodeHQL
Date Initiated2004-02-09
Date Terminated2005-01-04
Product QuantityNo quantity applies.

Reason for Recall

Risk of hyperopic refractive changes.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide and to Australia, Canada, Chile, France, Germany, India, Lebanon, South Africa, Switzerland, United Kingdom.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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