BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE ADVANCED OPTIC LENS

    MDR report key: 1892050 · Received October 26, 2010

    Report

    Report Number
    1119279-2010-00070
    Event Type
    Injury
    Date Received
    October 26, 2010
    Date of Event
    September 23, 2010
    Report Date
    September 27, 2010
    Manufacturer
    BAUSCH + LOMB
    Product Code
    HQL
    PMA / PMN Number
    P9100061
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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. ROOT CAUSE: ACCORDING TO THE PHYSICIAN, THE LIKELY ROOT CAUSE OF THE LENS DAMAGE WAS THE FOAM TIP PLUNGER OF THE INJECTOR OVERRODE THE IOL.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTS PERFORMING CATARACT SURGERY WITH ATTEMPTED IMPLANTATION OF A (B)(4) INTRAOCULAR LENS IN THE RIGHT EYE USING AN EZ-28 INJECTOR. DURING INSERTION OF THE LENS, THE PLUNGER KINKED THE TRAILING HAPTIC. INTERVENTION WAS PERFORMED IN ORDER TO ENLARGE THE ORIGINAL INCISION, REMOVE AND REPLACE THE LENS AND SUTURE THE WOUND. A SECOND (B)(4) LENS WAS IMPLANTED SUCCESSFULLY. REFERENCE MDR 1119279-2010-00071.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE ADVANCED OPTIC LENS INTRAOCULAR LENS HQL BAUSCH + LOMB LI61AOR 4017516

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention EZ-28 DELIVERY DEVICE (B+L)