BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE ADVANCED OPTIC LENS

    MDR report key: 1841612 · Received September 16, 2010

    Report

    Report Number
    1119279-2010-00036
    Event Type
    Injury
    Date Received
    September 16, 2010
    Date of Event
    August 17, 2010
    Report Date
    August 18, 2010
    Manufacturer
    BAUSCH + LOMB
    Product Code
    HQL
    PMA / PMN Number
    P910061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 DAMAGED LENS HAS BEEN RETURNED TO B+L AND IS CURRENTLY UNDERGOING EVAL. RESULTS WILL BE COMMUNICATED TO FDA IN A SUPPLEMENTAL REPORT. (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTS PERFORMING CATARACT SURGERY WITH IMPLANTATION OF THE LI61AOR INTRAOCULAR LENS USING THE EZ-28 DELIVERY DEVICE. DURING LENS INSERTION, THE CAPSULE WAS DAMAGED, THERE WAS VITREOUS FLUID LOSS, AND THE LENS HAPTIC WAS BENT. INTERVENTION WAS PERFORMED IN ORDER TO ENLARGE THE INCISION AND REMOVE AND REPLACE THE DAMAGED LENS. A VITRECTOMY WAS ALSO PERFORMED. A SECOND IOL WAS IMPLANTED SUCCESSFULLY AND THE PT'S PROGNOSIS IS EXCELLENT WITH 20/20 UCDVA. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE ADVANCED OPTIC LENS INTRAOCULAR LENS HQL BAUSCH + LOMB LI61AOR 4912504

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention EZ-28 DELIVERY DEVICE (B+L)