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Terminated

SoFlex UV-Absorbing Model LI61U Silicone Posterior Chamber Intraocular Lens.

FDA Recall Z-1093-04 · Posted 2004-07-20

Recalling FirmBausch & Lomb Surgical, Inc.
Recall StatusTerminated
Product CodeHQL
Date Initiated2004-02-27
Date Terminated2012-05-03
Product Quantity36

Reason for Recall

Lens may be labeled with incorrect diopter size.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide & puerto rico. FL, MA, CA, CT, MI, NY, IN, ID, GA, PA, IL, CO, TN, NC, PR, TX, ME and OH.

Official Source

View FDA Recall →

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

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