BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS ACCOMMODATING IOL

    MDR report key: 6192029 · Received December 20, 2016

    Report

    Report Number
    0001313525-2016-00831
    Event Type
    Injury
    Date Received
    December 20, 2016
    Report Date
    November 21, 2016
    Manufacturer
    BAUSCH + LOMB
    Product Code
    NAA
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LENS REMAINS IMPLANTED AND THE LOT NUMBER WAS NOT PROVIDED. THEREFORE, A PRODUCT EVALUATION AND DEVICE HISTORY RECORD REVIEW COULD NOT BE CONDUCTED. BASED ON THE CURRENT INFORMATION THE ROOT CAUSE OF THE 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 THERE WAS SOME TILT TO THE LENS POST-OP. ALLEGEDLY THERE IS OVER 2D OF Z-SYNDROME AND ALSO MARKED FIBROSIS. THE SURGEON IS EVALUATING TREATMENT OPTIONS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840963 CRYSTALENS ACCOMMODATING IOL LENS, INTRAOCULAR, ACCOMMODATIVE NAA BAUSCH + LOMB

    Patients

    Seq Age Sex Outcome Treatment
    1 Other