BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS

    MDR report key: 1895441 · Received November 4, 2010

    Report

    Report Number
    2031924-2010-00197
    Event Type
    Injury
    Date Received
    November 4, 2010
    Report Date
    October 4, 2010
    Manufacturer
    BAUSCH + LOMB
    Product Code
    NAA
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTS PERFORMING CATARACT SURGERY WITH BILATERAL IMPLANTATION OF THE CRYSTALENS. APPROXIMATELY ONE YEAR POSTOPERATIVELY THE SURGEON OBSERVED THAT BOTH LENSES HAD VAULTED IN A Z-CONFIGURATION. A YAG CAPSULOTOMY WAS PERFORMED IN BOTH EYES. ONE EYE (LENS #1) STABILIZED AND THE LENS REMAINS IMPLANTED. THE SECOND EYE (LENS #2) WENT FROM PLANO TO +2.75 + 4.00 AND THE PT'S UNCORRECTED VISUAL ACUITY WAS 20/200. THE PT WAS PRESCRIBED GLASSES CORRECTION AND THE IOL WAS SUBSEQUENTLY EXPLANTED AND REPLACED WITH A SULCUS-FIXATED IOL. ADDITIONAL INFO HAS BEEN REQUESTED. THIS REPORT IS FOR THE SECOND EYE (LENS# 2). REFERENCE MDR 2031924-2010-00196.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALENS INTRAOCULAR LENS NAA BAUSCH + LOMB

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention