BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE ADVANCED OPTIC LENS

    MDR report key: 1936068 · Received December 10, 2010

    Report

    Report Number
    1119279-2010-00123
    Event Type
    Injury
    Date Received
    December 10, 2010
    Date of Event
    August 15, 2006
    Report Date
    November 10, 2010
    Manufacturer
    BAUSCH + LOMB
    Product Code
    HQL
    PMA / PMN Number
    P910061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTS PERFORMING CATARACT SURGERY WITH IMPLANTATION OF THE LI61U INTRAOCULAR LENS IN THE RIGHT EYE. APPROX FOUR YEARS POSTOPERATIVELY WHITE SPECS ON THE POSTERIOR SURFACE OF THE OPTIC WERE NOTICED. A YAG CAPSULOTOMY WAS PERFORMED. NOW EIGHT YEARS POSTOPERATIVELY THE CONDITION HAS WORSENED. THE PT'S CURRENT VISUAL ACUITY HAS DECLINED TO 20/200 WITH MR -1.50 +1.00 X 045. THE PHYSICIAN IS CONSIDERING TREATMENT OPTIONS INCLUDING IOL EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE ADVANCED OPTIC LENS INTRAOCULAR LENS HQL BAUSCH + LOMB L161U

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention