BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALSERT CRYSTALENS DELIVERY SYSTEM

    MDR report key: 1940648 · Received December 22, 2010

    Report

    Report Number
    2031924-2010-00237
    Event Type
    Injury
    Date Received
    December 22, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 1, 2010
    Manufacturer
    BAUSCH & LOMB
    Product Code
    MSS
    PMA / PMN Number
    K082944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO B&L AND IS CURRENTLY UNDER EVAL. RESULTS WILL BE SUBMITTED TO THE FDA IN A SUPPLEMENTAL REPORT. (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTS PERFORMING CATARACT SURGERY WITH ATTEMPTED IMPLANTATION OF THE CRYSTALENS INTRAOCULAR LENS USING THE CI-28 DELIVERY DEVICE. DURING LENS INSERTION, THE PT HAD A HIP SPASM CAUSING HIS HEAD TO TURN INTO THE INJECTOR, RESULTING IN A TEAR OF THE RHEXIS EDGE. INTERVENTION WAS PERFORMED IN ORDER TO ENLARGE THE INCISION AND REMOVE THE LENS. ANOTHER INTRAOCULAR LENS WAS IMPLANTED SUCCESSFULLY. THE INCISION WOUND WAS SUTURED. REFERENCE MDR # 2031924-2010-00236.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention CRYSTALENS INTRAOCULAR LENS (B&L)