BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE ADVANCED OPTIC LENS

    MDR report key: 1991171 · Received February 7, 2011

    Report

    Report Number
    1119279-2011-00007
    Event Type
    Injury
    Date Received
    February 7, 2011
    Date of Event
    September 1, 2010
    Report Date
    November 9, 2010
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQL
    PMA / PMN Number
    P910061
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE RETURNED LENS FOUND BOTH HAPTICS BENT, NOT MEETING CURRENT STANDARDS. THE DELIVERY DEVICE WAS NOT RETURNED. THE CAUSE OF THE DAMAGE CANNOT BE DETERMINED. FUNCTIONAL TESTING CANNOT BE PERFORMED DUE TO THE DAMAGE. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS THAT RELATE TO THE REPORTED ISSUE. IN THE PHYSICIAN'S OPINION, THE LENS WAS RECEIVED DAMAGED. THE PHYSICIAN DID NOT PROVIDE ANY FURTHER DETAILS.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTS PERFORMING CATARACT SURGERY WITH ATTEMPTED IMPLANTATION OF THE LI61SE INTRAOCULAR LENS IN THE LEFT EYE USING THE EZ-28 DELIVERY DEVICE. DURING IOL INSERTION, THE PHYSICIAN NOTICED THAT THE LENS WAS TORN. THE INITIAL INCISION WAS ENLARGED IN ORDER TO REMOVE THE TORN LENS. A SECOND IOL WAS IMPLANTED SUCCESSFULLY WITHOUT COMPLICATIONS. REFERENCE MDR 1119279-2011-00008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE ADVANCED OPTIC LENS INTRAOCULAR LENS HQL BAUSCH & LOMB LI61SE 4006126

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention EZ-28 DELIVERY DEVICE (B+L)