BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS ACCOMMODATING IOL

    MDR report key: 6266835 · Received January 20, 2017

    Report

    Report Number
    0001313525-2017-00131
    Event Type
    Injury
    Date Received
    January 20, 2017
    Date of Event
    December 21, 2016
    Report Date
    December 22, 2016
    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

    INVESTIGATION OF THIS EVENT IS IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE LENS REMAINED IMPLANTED, THEREFORE IT WAS NOT RETURNED TO B+L FOR EVALUATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDING THAT RELATE TO THE REPORTED ISSUE. BASED ON THE CURRENT INFORMATION THE ROOT CAUSE OF THE EVENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON FEELS THERE WAS AN ANTERIOR LENS VAULT. REPORTEDLY THE SURGEON FOUND EVIDENCE OF PCO (POSTERIOR CAPSULAR OPACIFICATION) DURING EYE EXAM AND LENS WAS IN PLANAR POSITION WITH OPEN HINGE. THE SURGEON IS EVALUATING TREATMENT OPTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51597 CRYSTALENS ACCOMMODATING IOL LENS, INTRAOCULAR, ACCOMMODATIVE NAA BAUSCH + LOMB AT52AO 7554204

    Patients

    Seq Age Sex Outcome Treatment
    1 Other