BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS ACCOMMODATING IOL

    MDR report key: 3893764 · Received June 11, 2014

    Report

    Report Number
    2031924-2014-00119
    Event Type
    Injury
    Date Received
    June 11, 2014
    Date of Event
    November 25, 2013
    Report Date
    May 14, 2014
    Manufacturer
    BAUSCH + LOMB
    Product Code
    NAA
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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

    THE CONSUMER ALLEGED THAT AN INCORRECT REFRACTIVE POWER LENS WAS IMPLANTED IN HIS LEFT EYE. THE CONSUMER ALSO ALLEGED THAT THE LENS DEVELOPED "Z-SYNDROME". ACCORDING TO THE CONSUMER, THE LENS WAS REMOVED AND REPLACED WITH A NON-ACCOMMODATING LENS OF THE CORRECT REFRACTIVE SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345227 CRYSTALENS ACCOMMODATING IOL NAA/LENS, INTRAOCULAR, ACCOMODATIVE NAA BAUSCH + LOMB AT52AO

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other