BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS ACCOMMODATING IOL

    MDR report key: 3954726 · Received July 18, 2014

    Report

    Report Number
    2031924-2014-00157
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    Product Code
    NAA
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LENS HAS BEEN RETURNED TO B+L AND IS CURRENTLY UNDER 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 LENS COULD NOT BE POSITIONED PROPERLY DUE TO A BENT HAPTIC. THE INCISION WAS ENLARGED, THE LENS WAS REMOVED INTRAOPERATIVELY AND A BACKUP LENS WAS IMPLANTED. THIS EVENT REFERS TO THE PATIENT'S RIGHT EYE. ACCORDING TO THE SURGEON THE PATIENT IS HEALING NORMALLY POST-OP. NO SPECIFIC INFORMATION REGARDING THE INSERTER USED DURING THE EVENT HAS BEEN RECEIVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422140 CRYSTALENS ACCOMMODATING IOL LENS, INTRAOCULAR, ACCOMMODATIVE NAA AT50AO

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other