BEUDAMED
    FDA Recall Terminated

    OPTIMA FW (polymacon) Visibility Tinted Contact Lenses, labeled as -2.25D, 8.7 mm. Responsible firm on the label: Bausch & Lomb Inc., Rochester, NY 14692. Each box contains six lenses.

    Recall: Z-0348-03 · Initiated November 26, 2002

    Recall

    Recall Number
    Z-0348-03
    Event Number
    25105
    Firm
    Bausch & Lomb Inc
    FEI Number
    1317628
    Product Code
    LPM
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 26, 2002
    Posted
    December 19, 2002
    Terminated
    June 23, 2003
    Address
    1400 North Goodman St P.O. Box 30450, Rochester, NY, 14609

    Description

    OPTIMA FW (polymacon) Visibility Tinted Contact Lenses, labeled as -2.25D, 8.7 mm. Responsible firm on the label: Bausch & Lomb Inc., Rochester, NY 14692. Each box contains six lenses.

    Reason

    Lenses labeled as -2.25 diopter contain -0.75 diopter lenses.

    Action

    Letters dated 12/2/02 issued to distributors and practitioners requesting return of the affected lot.

    Distribution

    Nationwide distribution.

    Quantity

    2,081 / 6-packs