BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS ACCOMMODATING IOL

    MDR report key: 5099351 · Received September 24, 2015

    Report

    Report Number
    0001313525-2015-02632
    Event Type
    Injury
    Date Received
    September 24, 2015
    Date of Event
    August 11, 2015
    Report Date
    August 26, 2015
    Manufacturer
    BAUSCH & LOMB INCORPORATED
    Product Code
    NAA
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LENS REMAINED IMPLANTED. THEREFORE, A PRODUCT EVALUATION COULD NOT BE CONDUCTED. ONE RETAIN SAMPLE FROM THE SAME LOT (022428) WAS DIMENSIONALLY INSPECTED AND ALL MEASUREMENTS WERE FOUND TO BE WITHIN SPECIFICATIONS. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDING THAT RELATE TO THE REPORTED ISSUE. BASED ON THE INFORMATION AVAILABLE, THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 1

    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 PATIENT HAS A MILD ASYMMETRICAL LENS TILT IN THE RIGHT EYE NOTED APPROXIMATELY 4 MONTHS POST LENS IMPLANT. A YAG PROCEDURE WAS PERFORMED ON (B)(6) 2015 UNDER THE ANTERIORLY VAULTED PLATE. THE SURGEON INDICATED THAT THE LIKELY CAUSE OF THE EVENT WAS CAPSULAR CONTRACTION. THE PATIENT'S PROGNOSIS IS FAIR TO GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633721 CRYSTALENS ACCOMMODATING IOL LENS, INTRAOCULAR, ACCOMMODATIVE NAA BAUSCH & LOMB INCORPORATED AT50AO 022428

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other