BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE ADVANCED OPTIC LENS

    MDR report key: 2040980 · Received March 25, 2011

    Report

    Report Number
    1119279-2011-00069
    Event Type
    Injury
    Date Received
    March 25, 2011
    Date of Event
    February 25, 2011
    Report Date
    February 25, 2011
    Manufacturer
    BAUSCH + LOMB
    Product Code
    HQL
    PMA / PMN Number
    P910061
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LENS HAS BEEN RETURNED TO B+L AND IS CURRENTLY UNDER EVAL. RESULTS WILL BE SUBMITTED TO THE FDA IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE SURGEON REPORTS PERFORMING CATARACT SURGERY WITH AN ATTEMPTED IMPLANTATION OF AN LI61AOR IOL USING THE EZ-28 DELIVERY SYSTEM. DURING SURGERY WEAK ZONULES AND A CAPSULAR TEAR WERE NOTED. DUE TO THE ZONULAR INSUFFICIENCY IT WAS DECIDED TO REMOVE THE LENS THROUGH AN ENLARGED INCISION AND REPLACE IT WITH AN ANTERIOR CHAMBER LENS. PLEASE REFERENCE MDR #: 1119279-2011-00070.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE ADVANCED OPTIC LENS INTRAOCULAR LENS HQL BAUSCH + LOMB LI61AOR 4027812

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EZ-28 DELIVERY SYSTEM