BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 3232635 · Received July 18, 2013

    Report

    Report Number
    9614546-2013-00120
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    May 21, 2013
    Report Date
    June 25, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS (IOL) WAS RETURNED TO THE MANUFACTURER. THE IOL WAS CUT IN TWO PARTS. A FEW LOOSE PARTICLES WERE OBSERVED IN THE OPTIC ZONE COMPATIBLE WITH HANDLING THE LENS OUT OF A STERILE ENVIRONMENT. AT 10X MAGNIFICATION THE CIRCULAR ZONES ACROSS THE OPTIC WERE OBSERVED, INDICATING THE LENS IS A ZMB00 MODEL. THE CONDITION OF THE RETURNED LENS WAS CONSISTENT WITH ONE THAT HAS BEEN IMPLANTED AND EXPLANTED FROM THE PATIENT'S EYE. DIOPTER MEASUREMENT WAS NOT PERFORMED AS THE CONDITION OF THE LENS WAS NOT ADEQUATE FOR DIOPTER MEASUREMENT. HOWEVER, THE LENS DIOPTER WAS VERIFIED DURING MANUFACTURING MIQ (STORED DATA) AND MATCHES THE LABELED DIOPTER. THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED. MANUFACTURING RECORDS WERE REVIEWED. ALL PROCESS OPERATIONS PRESENTED IN THE MANUFACTURING RECORD FROM GENERATION TO BOXING WERE IN COMPLIANCE WITH MANUFACTURING INSTRUCTIONS SPECIFICATIONS. ALL TESTS RESULTS SHOWED A PASS CONDITION. NO QUANTITY DISCREPANCY WAS FOUND. NO DEVIATION OR NON-CONFORMANCE (NCR) RELATED TO THE CUSTOMER CLAIM WAS GENERATED. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: (B)(6). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. MFR REPORT # SHOULD HAVE BEEN 2648035.

    Additional Manufacturer Narrative · 1

    (B)(4). EXPLANT OF INTRAOCULAR LENS. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    WE RECEIVED A REPORT CONCERNING A PATIENT WHERE AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE RIGHT EYE AFTER THE PATIENT EXPERIENCED UNEXPECTED POST-OPERATIVE REFRACTION. NO SUTURES WERE REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333870 TECNIS 1 MULTIFOCAL MULTIFOCAL IOLS MFK ABBOTT MEDICAL OPTICS ZMB00

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention