BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASY LOAD INSERTER

    MDR report key: 1893215 · Received October 29, 2010

    Report

    Report Number
    1119279-2010-00079
    Event Type
    Injury
    Date Received
    October 29, 2010
    Date of Event
    August 19, 2010
    Report Date
    August 24, 2010
    Manufacturer
    BAUSCH & LOMB
    Product Code
    MSS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTS PERFORMING CATARACT SURGERY WITH ATTEMPTED IMPLANTATION OF THE (B)(4) INTRAOCULAR LENS USING THE EZ-28 DELIVERY DEVICE. DURING INSERTION, THE CAPSULE WAS DAMAGED AND COULD NOT SUPPORT THE LENS. THE (B)(4) WAS REMOVED AND REPLACED WITH AN ANTERIOR CHAMBER IOL AND THE INCISION WAS SUTURED. REFERENCE MDR 1119279-2010-00076.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASY LOAD INSERTER IOL INSERTER/INJECTOR MSS BAUSCH & LOMB EZ-28

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention (B)(4) INTRAOCULAR LENS (B&L)