BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS INTRAOCULAR LENS

    MDR report key: 4098215 · Received September 5, 2014

    Report

    Report Number
    2031924-2014-00229
    Event Type
    Injury
    Date Received
    September 5, 2014
    Date of Event
    March 20, 2014
    Report Date
    August 7, 2014
    Manufacturer
    BAUSCH + ;PMB
    Product Code
    NAA
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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 THE LENS VAULTED ASYMMETRICALLY (Z-SYNDROME) APPROX 3 MONTHS POST LENS IMPLANT. THE PT ALSO NOTED A DECREASE IN VISION. THE SURGEON PERFORMED A PC YAG AND A LENS REPOSITION WITH CTR ON (B)(6) 2014. THE LENS WAS SUBSEQUENTLY EXCHANGED WITH ANOTHER MODEL AND DIOPTER LENS. AN ANTERIOR VITRECTOMY WAS ALSO REPORTED, HOWEVER, IT IS UNK IF THIS OCCURRED PRIOR TO THE LENS EXCHANGE. ACCORDING TO THE SURGEON, THE LIKELY CAUSE OF THE EVENT IS "CAPSULAR CONTRACTION". THE PT'S PROGNOSIS IS GOOD. THIS REPORT REFERS TO PT'S LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543722 CRYSTALENS INTRAOCULAR LENS LENS, INTRAOCULAR, ACCOMMODATIVE NAA BAUSCH + ;PMB AT50AO

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other