BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 4140875 · Received October 3, 2014

    Report

    Report Number
    2648035-2014-00522
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    July 9, 2014
    Report Date
    September 10, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS (IOL) WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE IOL WAS VISUALLY INSPECTED UNDER A MICROSCOPE. VISUAL INSPECTION REVEALED SURFACE RESIDUALS (FIBER/PARTICLES) ON THE LENS THAT MAY BE RELATED TO HANDLING THE LENS IN A NON-STERILE ENVIRONMENT. ALSO, THE LENS WAS RETURNED CUT IN TWO PIECES. THE LENS CONDITION IS CONSISTENT WITH A LENS THAT HAD BEEN EXPLANTED FROM THE PATIENT'S EYE. DUE TO THE RETURNED LENS CONDITION, DIOPTER MEASUREMENT COULD NOT BE PERFORMED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS AT THE TIME OF THIS REPORT HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED. ALL PROCESS OPERATIONS PRESENTED IN THE MANUFACTURING RECORD FROM GENERATION TO BOXING WERE IN COMPLIANCE WITH MANUFACTURING INSTRUCTION SPECIFICATIONS. ALL TESTS RESULTS SHOWED A PASS CONDITION. NO QUANTITY DISCREPANCY WAS FOUND. NO DEVIATION OR NON-CONFORMANCE (NCR) WAS GENERATED DURING THE MANUFACTURING OF THE PRODUCTION ORDER. THE LENS MET MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTRAOCULAR LENS WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE IN A SECONDARY PROCEDURE DUE TO A MYOPIC OUTCOME AFTER THE LENS WAS IMPLANTED. IT WAS STATED THAT THERE WAS NO USE ERROR, THE INCISION WAS NOT ENLARGED AND A VITRECTOMY WAS NOT PERFORMED. THERE WAS NO PATIENT INJURY REPORTED. THE PATIENT WAS REPORTED TO BE DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620750 TECNIS 1 MULTIFOCAL MULTIFOCAL IOLS MFK ABBOTT MEDICAL OPTICS ZMB00

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention