BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS HD

    MDR report key: 1991168 · Received February 7, 2011

    Report

    Report Number
    2031924-2011-00012
    Event Type
    Injury
    Date Received
    February 7, 2011
    Report Date
    December 9, 2010
    Manufacturer
    BAUSCH + LOMB
    Product Code
    NAA
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDING THAT RELATE TO THE REPORTED ISSUE. THE INTRAOCULAR LENS IS IMPLANTED.

    Description of Event or Problem · 1

    BAUSCH + LOMB RECEIVED A TELEPHONE COMMUNICATION FROM A CONSUMER WHO UNDERWENT IMPLANTATION OF THE CRYSTALENS INTRAOCULAR LENS BILATERALLY. THIS REPORT REFERS TO THE LEFT EYE. APPROXIMATELY THREE MONTHS POSTOPERATIVELY, THE PATIENT STARTED EXPERIENCING BLURRY VISION AND SEEING FLOATERS. AFTER APPROXIMATELY 22 MONTHS POSTOPERATIVELY, A YAG CAPSULOTOMY WAS PERFORMED. THE PATIENT HAS DECIDED TO POSTPONE ORDERING PRESCRIPTION GLASSES AND WAIT FOR THE OUTCOME OF THE YAG TREATMENT ON THE LEFT EYE. ACCORDING TO THE PROVIDED INFORMATION, CURRENT VISUAL ACUITY IS 20/60 (UNKNOWN IF BEST CORRECTED). REFERENCE MDR: 2031924-2011-00013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALENS HD INTRAOCULAR LENS NAA BAUSCH + LOMB HD500 016647

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention