BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS INTRAOCULAR LENS

    MDR report key: 4810575 · Received May 29, 2015

    Report

    Report Number
    1313525-2015-01550
    Event Type
    Injury
    Date Received
    May 29, 2015
    Report Date
    May 8, 2015
    Manufacturer
    BAUSCH & LOMB,
    Product Code
    NAA
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE LENS WAS NOT PROVIDED, AND THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. THEREFORE, A DEVICE HISTORY REVIEW (DHR) AND PRODUCT EVALUATION COULD NOT BE CONDUCTED. BASED ON THE INFORMATION CURRENTLY AVAILABLE THE ROOT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 1

    THE LENS REMAINS IMPLANTED; THEREFORE, IT IS NOT AVAILABLE FOR EVALUATION. INVESTIGATION IS UNDERWAY. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ASYMMETRIC VAULT MANIFESTED LESS THAN ONE DAY POST IMPLANT. THE IOL WAS REPOSITIONED ON THE SAME DAY AND THE PATIENT WAS REPORTED AS "CURRENTLY STABLE". IN THE SURGEON'S OPINION THE LIKELY CAUSE OF THE EVENT IS THE PATIENT RUBBING HIS EYE. THIS REPORT PERTAINS TO THE PATIENT'S RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349696 CRYSTALENS INTRAOCULAR LENS LENS,INTRAOCULAR,ACCOMMODATIVE NAA BAUSCH & LOMB,

    Patients

    Seq Age Sex Outcome Treatment
    1 Other