BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS

    MDR report key: 1760554 · Received July 14, 2010

    Report

    Report Number
    2031924-2010-00125
    Event Type
    Injury
    Date Received
    July 14, 2010
    Date of Event
    March 11, 2010
    Report Date
    April 22, 2010
    Manufacturer
    BAUSCH + LOMB
    Product Code
    NAA
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 WAS RETURNED TO B+L AND SUBJECTED TO VISUAL EXAMINATION. THE HAPTIC WAS BENT ON THE LEADING HAPTIC PLATE AND THE OPTIC WAS TORN. THE TRAILING HAPTIC WAS ALSO BENT AND HAD TEARS IN TWO PLACES. THE CONDITION OF THE LENS IS CONSISTENT WITH LENS DAMAGE ASSOCIATED WITH LENS INJECTOR USE. ROOT CAUSE: ACCORDING TO THE SURGEON, THE ROOT CAUSE OF THE REPORTED ISSUE OF LENS DAMAGE IS ATTRIBUTABLE TO THE INSERTION DEVICE, WHERE THE PLUNGER OVERRODE THE IOL.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTS THAT DURING CATARACT SURGERY, THE CRYSTALENS HAPTIC TORE DURING DELIVERY USING THE CRYSTALSERT LENS INJECTION SYSTEM. INTERVENTION WAS PERFORMED IN ORDER TO ENLARGE THE INCISION AND REMOVE AND REPLACE THE LENS AND SUTURE THE INCISION. A SECOND IOL WAS IMPLANTED SUCCESSFULLY. REFERENCE MDR # 2031924-2010-00126.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALENS INTRAOCULAR LENS NAA BAUSCH + LOMB AT52AO 018109

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CRYSTALSERT LENS INJECTOR (B+L)