BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS INTRAOCULAR LENS

    MDR report key: 3708448 · Received March 14, 2014

    Report

    Report Number
    2031924-2014-00043
    Event Type
    Injury
    Date Received
    March 14, 2014
    Report Date
    February 12, 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 IS UNDERWAY. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 3 PATIENTS DEVELOPED Z-SYNDROME. YAG WAS PERFORMED WITHOUT SUCCESS. THE DOCTOR EXPLANTED 2 OF THE 3 LENSES. AT THIS TIME, IT IS UNKNOWN WHICH PATIENT HAS HAD WHAT INTERVENTION. THIS REPORT REFERS TO PATIENT 1 OF 3. PLEASE REFERENCE 2031924-2014-00044 FOR PATIENT 2 OF 3. PLEASE REFERENCE 2031924-2014-00045 FOR PATIENT 3 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154914 CRYSTALENS INTRAOCULAR LENS NAA; LENS, INTRAOCULAR, ACCOMODATIVE NAA BAUSCH + LOMB

    Patients

    Seq Age Sex Outcome Treatment
    1 Other