BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS ACCOMODATING IOL

    MDR report key: 4092300 · Received August 20, 2014

    Report

    Report Number
    2031924-2014-00206
    Event Type
    Injury
    Date Received
    August 20, 2014
    Report Date
    July 21, 2014
    Product Code
    NAA
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 A PATIENT HAD AN ANTERIOR LENS TILT WHICH THE DOCTOR SUCCESSFULLY TREATED WITH A YAG. THE PATIENT RETURNED MONTHS LATER WITH A RECURRENT TILT IN THE OPPOSITE DIRECTION. THE DOCTOR PLANNED A SECOND YAG TREATMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NO ADDITIONAL INFORMATION HAS BEEN RECEIVED BY BAUSCH AND LOMB TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503943 CRYSTALENS ACCOMODATING IOL LENS, INTRAOCULAR, ACCOMODATIVE NAA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other