BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS INTRAOCULAR LENS

    MDR report key: 3940621 · Received June 24, 2014

    Report

    Report Number
    2031924-2014-00137
    Event Type
    Injury
    Date Received
    June 24, 2014
    Date of Event
    November 1, 2013
    Report Date
    January 17, 2014
    Manufacturer
    BAUSCH AND LOMB
    Product Code
    NAA
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LENS REMAINS IMPLANTED, THEREFORE IT IS NOT AVAILABLE FOR EVALUATION. THE LENS SERIAL/LOT NUMBER HAS NOT BEEN PROVIDED, THEREFORE A DEVICE HISTORY RECORD (DHR) COULD NOT BE PERFORMED. BASED ON THE CURRENT INFORMATION THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THAT APPROXIMATELY 1 YEAR AND 2 MONTHS POST LENS IMPLANTATION SHE EXPERIENCED DOUBLE VISION IN HER LEFT EYE AND DIFFICULTY WITH HER NIGHT VISION. THE CONSUMER INDICATED THAT ACCORDING TO HER SURGEON THE LENS WAS DISLOCATED/FLEXED AND SHE HAD A SECOND SURGERY ON (B)(6) 2014 TO "STRAIGHTEN OUT" THE LENS WHICH RESOLVED HER SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367512 CRYSTALENS INTRAOCULAR LENS NAA; LENS, INTRAOCULAR, ACCOMMODATIVE NAA BAUSCH AND LOMB

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other