BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE ADVANCED OPTIC LENS

    MDR report key: 2023374 · Received March 16, 2011

    Report

    Report Number
    1119279-2011-00062
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    November 29, 2010
    Report Date
    February 14, 2011
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQL
    PMA / PMN Number
    P910061
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE SURGEON REPORTS PERFORMING CATARACT SURGERY WITH IMPLANTATION OF AN LI61AO INTRAOCULAR LENS IN THE LEFT EYE USING THE EZ-28 DELIVERY SYSTEM. APPROX FOUR MONTHS POSTOPERATIVELY, THE PT PRESENTED WITH GLARE, STREAKS OF LIGHT, BLURRED VISION, AND GHOSTING. ACCORDING TO THE SURGEON, A SMALL TEAR IN THE CAPSULE WHICH OCCURRED DURING THE PROCEDURE CAUSED THE IOL TO BECOME DECENTERED. THE IOL WAS FREE OF DEBRIS/DEPOSITS. THE IOL WAS SUBSEQUENTLY EXPLANTED, AND ANOTHER LI61AO LENS (20.00 D) WAS IMPLANTED SUCCESSFULLY. POSTOPERATIVELY, BEFORE THE LENS EXCHANGE, THE PT'S UCDVA WAS 20/40-2. AFTER INTERVENTION, THE PT'S UCDVA IS 20/20-1. ACCORDING TO THE SURGEON, THE PT'S CURRENT PROGNOSIS IS GOOD AND NO ADDITIONAL TREATMENT IS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE ADVANCED OPTIC LENS INTRAOCULAR LENS HQL BAUSCH & LOMB LI61AO 4012608

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention EZ-28 DELIVERY SYSTEM