BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS ACCOMMODATING IOL

    MDR report key: 2780371 · Received October 5, 2012

    Report

    Report Number
    2031924-2012-00077
    Event Type
    Injury
    Date Received
    October 5, 2012
    Date of Event
    August 31, 2012
    Report Date
    September 6, 2012
    Manufacturer
    BAUSCH + LOMB
    Product Code
    NAA
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THIS EVENT IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CRYSTALENS WAS EXPLANTED/EXCHANGED FIVE WEEKS POSTOPERATIVELY FOR STANDARD MONOFOCAL LENS TO ADDRESS ASYMMETRICAL LENS VAULTING. THE PT'S PREOPERATIVE MANIFEST REFRACTION WAS +1.25 -0.50 X135 WITH BCVA OF 20/30. BEFORE IOL EXCHANGE, PT'S BCVA WAS 20/40. THE PT'S UCVA AFTER IOL EXCHANGE WAS 20/70. THE SURGEON INDICATED THAT IN HIS OPINION, THE LIKELY CAUSE OF THE EVENT WAS FIBROSIS/PREMATURE CAPSULAR CONTRACTION. THE PT'S CURRENT PROGNOSIS IS GOOD. THIS EVENT REFERS TO THE PT'S LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALENS ACCOMMODATING IOL NAA LENS, INTRAOCULAR, ACCOMMODATIVE NAA BAUSCH + LOMB AT-50AO

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other