BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS

    MDR report key: 2175352 · Received July 20, 2011

    Report

    Report Number
    2031924-2011-00124
    Event Type
    Injury
    Date Received
    July 20, 2011
    Report Date
    June 14, 2011
    Manufacturer
    BAUSCH + LOMB
    Product Code
    NAA
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER INDICATED THAT THE EXPLANTED LENS WOULD NOT BE RETURNED TO BAUSCH AND LOMB. THEREFORE, THE EXPLANTED IOL IS NOT AVAILABLE FOR EVALUATION. INVESTIGATION OF THIS EVENT IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH SUDDEN ONSET OF Z-SYNDROME AND DECREASE IN VISION FIVE WEEKS AFTER CRYSTALENS IMPLANTATION. SUBSEQUENTLY THE LENS WAS EXCHANGED FOR ANOTHER CRYSTALENS WITH A HIGHER DIOPTER POWER, AND A CAPSULAR TENSION RING (CTR) WAS PLACED TO PREVENT RECURRENCE. AFTER THE LENS EXCHANGE, THE PATIENT'S UNCORRECTED DISTANCE VISUAL ACUITY (UCDVA) WAS 20/25+2 AND THE PATIENT IS VERY HAPPY WITH THE OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALENS INTRAOCULAR LENS NAA BAUSCH + LOMB AT52AO 019158

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention