BEUDAMED
    FDA Adverse Event Other Summary report: N

    BAUSCH AND LOMB PUR VISION LENSES

    MDR report key: 2872409 · Received October 25, 2012

    Report

    Report Number
    1281950-2012-00001
    Event Type
    Other
    Date Received
    October 25, 2012
    Report Date
    October 16, 2012
    Manufacturer
    BAUSCH & LOMB
    Product Code
    LPL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    LOT # R18532474.

    Description of Event or Problem · 1

    A VOICE MAIL WAS RECEIVED ON (B)(6) 2012 FROM THE PATIENT REPORTING EYE INFECTIONS IN BOTH EYES. ON (B)(6) 2012 AND E-MAIL WAS RECEIVED FROM PATIENT STATING HE WEARS PURE VISION LENSES. BAUSCH AND LOMB MANUFACTURES THE PURE VISION LENSES. THE PRODUCT WAS IDENTIFIED IS A BAUSCH AND LOMB PRODUCT AS PURE VISION LENSES. COOPERVISION, INC. DID NOT MANUFACTURE THIS PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAUSCH AND LOMB PUR VISION LENSES NONE LPL BAUSCH & LOMB R185341407

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention