BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALSERT CRYSTALENS DELIVERY SYSTEM

    MDR report key: 1870960 · Received October 8, 2010

    Report

    Report Number
    2031924-2010-00173
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    August 4, 2010
    Report Date
    September 8, 2010
    Manufacturer
    BAUSCH + LOMB
    Product Code
    MSS
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, 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 LENS INJECTOR WAS RETURNED TO B+L AND SUBJECTED TO VISUAL INSPECTED WHICH REVEALED THAT THE IOL TRAILING HAPTIC AND HAPTIC LOOP WERE STILL PRESENT IN THE INJECTOR AND THE NOZZLE TIP WAS BENT. PRESENCE OF FOREIGN MATERIAL (PRESUMED TO BE VISCOELASTIC) WAS OBSERVED IN THE LOADING CHAMBER AND NOZZLE TIP. THE CONDITION OF THE LENS IS CONSISTENT WITH DAMAGE RESULTING FROM USE.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTS PERFORMING CATARACT SURGERY WITH ATTEMPTED IMPLANTATION OF THE CRYSTALENS USING THE CRYSTALSERT LENS INJECTOR SYS. DURING THE PROCEDURE, THE SURGEON NOTICED THAT THE HAPTIC WAS DAMAGED. INTERVENTION WAS PERFORMED IN ORDER TO ENLARGE THE INCISION, REMOVE THE DAMAGED LENS, AND SUTURE THE INCISION. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALSERT CRYSTALENS DELIVERY SYSTEM IOL INSERTER/INJECTOR MSS BAUSCH + LOMB CI-28 H007805

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CRYSTALENS INTRAOCULAR LENS (B+L)