BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS ACCOMMODATING IOL

    MDR report key: 3850508 · Received May 21, 2014

    Report

    Report Number
    2031924-2014-00102
    Event Type
    Injury
    Date Received
    May 21, 2014
    Date of Event
    May 8, 2013
    Report Date
    April 22, 2014
    Manufacturer
    BAUSCH + LOMB
    Product Code
    NAA
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THIS EVENT ISD IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CAPSULE TORE DURING LENS INSERTION WHICH CAUSED DECENTRATION OF THE LENS. THE LENS WAS EXPLANTED AND REPLACED 1 DAY POST OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303009 CRYSTALENS ACCOMMODATING IOL NAA/LENS, INTRAOCULAR, ACCOMODATIVE NAA BAUSCH + LOMB AT52AO

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other