BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS AO

    MDR report key: 2000964 · Received February 18, 2011

    Report

    Report Number
    2031924-2011-00041
    Event Type
    Injury
    Date Received
    February 18, 2011
    Date of Event
    January 6, 2011
    Report Date
    January 21, 2011
    Manufacturer
    BAUSCH + LOMB
    Product Code
    NAA
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS THAT RELATE TO THE REPORTED ISSUE. VISUAL INSPECTION OF LENS REVEALED A DIAGONAL TEAR THROUGHOUT THE OPTIC. ALSO, A PARTIAL PORTION OF THE OPTIC AND THE ENTIRE ADJACENT TRAILING HAPTIC PLATE ARE MISSING. THE CONDITION OF THE RETURNED LENS IS CONSISTENT WITH AN EXPLANTED LENS. DUE TO THE DAMAGE, NO MEASUREMENTS COULD BE PERFORMED FOR THE RETURNED LENS. HOWEVER, ONE RETAIN SAMPLE FROM LOT# 019145 WAS INSPECTED DIMENSIONALLY AND ALL MEASUREMENTS WERE WITHIN SPECIFICATIONS. DIMENSIONAL MEASUREMENTS WERE UNABLE TO BE PERFORMED DUE TO THE TORN CONDITION OF THE LENS.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTS THAT A PT UNDERWENT CATARACT SURGERY WITH IMPLANTATION OF THE CRYSTALENS IN THE LEFT EYE. APPROX 1 MONTH POSTOPERATIVELY, THE LENS VAULTED IN A Z-CONFIGURATION AND THE LENS WAS SUBSEQUENTLY EXPLANTED AND REPLACED WITH ANOTHER IOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALENS AO INTRAOCULAR LENS NAA BAUSCH + LOMB AT50AO 019145

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention