BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS ACCOMODATING IOL

    MDR report key: 3005958 · Received March 12, 2013

    Report

    Report Number
    2031924-2013-00050
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    November 28, 2012
    Report Date
    January 25, 2012
    Manufacturer
    BAUSCH AND LOMB
    Product Code
    NAA
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN REQUESTED, BUT HAS NOT BE RECEIVED FOR EVALUATION. 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 CRYSTALENS WAS EXPLANTED/EXCHANGED FOR A DIFFERENT MODEL LENS APPROXIMATELY NINE MONTHS POSTOPERATIVELY TO ADDRESS ASYMMETRICAL VAULTING CAUSED BY AGGRESSIVE CAPSULAR CONTRACTION AND POSTERIOR CAPSULAR OPACIFICATION (PCO). ACCORDING TO THE SURGEON LACK OF FOLLOW UP BY PATIENT MAY HAVE EXACERBATED PROBLEM BY DELAYING EARLY INTERVENTION. ACCORDING TO THE SURGEON, THE PATIENT'S PROGNOSIS IS EXCELLENT. THIS EVENT PERTAINS TO THE PATIENT'S LEFT EYE. REFERENCE MDR #2031924-2013-00049, FOR THE INTRAOCULAR LENS IMPLANTED IN THE PATIENT'S RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103453 CRYSTALENS ACCOMODATING IOL NAA/LENS, INTRAOCULAR, ACOMODATIVE NAA BAUSCH AND LOMB AT52AO

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other