BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE ADVANCED OPTIC LENS

    MDR report key: 1910786 · Received November 23, 2010

    Report

    Report Number
    1119279-2010-00096
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    September 30, 2010
    Report Date
    October 27, 2010
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQL
    PMA / PMN Number
    P910061
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE REVIEWED, AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS THAT RELATE TO THE REPORTED ISSUE. THE DEVICE HAS BEEN RETURNED TO B&L AND IS CURRENTLY UNDERGOING EVAL.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTS PERFORMING CATARACT SURGERY WITH ATTEMPTED IMPLANTATION OF THE LI61AOR INTRAOCULAR LENS USING THE EZ-28 DELIVERY DEVICE. AFTER THE LENS WAS INSERTED, THE SURGEON NOTICED THE OPTIC WAS SCRATCHED. THE LENS WAS REMOVED AND SUCCESSFULLY REPLACED WITH A SECOND L161AOR. ONE SUTURE WAS REQUIRED TO CLOSE THE WOUND. ADDITIONAL INFO HAS BEEN REQUESTED. REFERENCE MDR #1119279-2010-00097.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE ADVANCED OPTIC LENS INTRAOCULAR LENS HQL BAUSCH & LOMB LI61AOR 4013018

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention EZ-28 DELIVERY DEVICE (B&L)