BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS ACCOMMADTING IOL

    MDR report key: 4081121 · Received August 29, 2014

    Report

    Report Number
    2031924-2014-00223
    Event Type
    Injury
    Date Received
    August 29, 2014
    Date of Event
    June 11, 2014
    Report Date
    August 1, 2014
    Manufacturer
    BAUSCH + LOMB
    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

    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 PT PRESENTED WITH "Z-SYNDROME." APPROXIMATELY 1 MONTH POST IMPLANTATION, THE LENS WAS REPOSITIONED. ADDITIONAL INFO HAS BEEN REQUESTED, BUT NO ADDITIONAL INFO HAS BEEN RECEIVED BY BAUSCH + LOMB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527599 CRYSTALENS ACCOMMADTING IOL LENS, INTRAOCULAR, ACCOMODATIVE NAA BAUSCH + LOMB AT50AO 7449206

    Patients

    Seq Age Sex Outcome Treatment
    1 Other