BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS

    MDR report key: 1970356 · Received January 14, 2011

    Report

    Report Number
    2031924-2011-00026
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    November 29, 2010
    Report Date
    January 4, 2011
    Manufacturer
    BAUSCH & LOMB
    Product Code
    NAA
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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. (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTS PERFORMING CATARACT SURGERY WITH ATTEMPTED IMPLANTATION OF A CRYSTALENS. DURING THE INSERTION OF THE FIRST LENS, THE LENS TWISTED UPSIDE DOWN. THE SURGEON WAS UNABLE TO REPOSITION THE LENS AND SUBSEQUENTLY REMOVED IT. INSERTION OF A BACK-UP CRYSTALENS WAS ATTEMPTED, BUT THE LENS WAS INSERTED UPSIDE DOWN AND COULD NOT BE REPOSITIONED. UPON REMOVAL OF THE SECOND CRYSTALENS, THE CAPSULAR BAG WAS FOUND RUPTURED. A VITRECTOMY WAS PERFORMED. A SULCUS LENS WAS SUCCESSFULLY IMPLANTED. THIS REPORT REFERS TO THE FIRST LENS. REFERENCE MDR # 2031924-2011-00001.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALENS INTRAOCULAR LENS NAA BAUSCH & LOMB HD520 015637

    Patients

    Seq Age Sex Outcome Treatment
    1