BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS INTRAOCULAR LENS

    MDR report key: 4112848 · Received September 17, 2014

    Report

    Report Number
    2031924-2014-00240
    Event Type
    Injury
    Date Received
    September 17, 2014
    Report Date
    August 18, 2014
    Manufacturer
    BAUMB + LOMB SURGICAL
    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

    INVESTIGATION IS UNDERWAY. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO SMALL LUMPS OF VITREOUS FACE WERE NOTED AROUND THE SUPERIOR IOL OPTIC ON BOTH SIDES. ONE OF THE VITREOUS FACE LUMPS EXTENDS INTO THE VISUAL AXIS. BEFORE LENS IMPLANT PATIENT HAD POSTERIOR SUB-CAPSULAR CATARACT (PSC) AND SYMPTOMS OF GLARE. THREE MONTHS POST LENS IMPLANTATION, THE PATIENT EXPERIENCED BASELINE GLARE AGAIN DUE TO POSTERIOR CAPSULE OPACIFICATION (PCO). A YAG CAPSULOTOMY WAS PERFORMED, BUT DID NOT RESOLVE THE ISSUE. THIS EVENT REFERENCES THE PATIENT'S RIGHT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NO NEW INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577220 CRYSTALENS INTRAOCULAR LENS LENS, INTRAOCULAR, ACCOMMODATIVE NAA BAUMB + LOMB SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other