BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 3870806 · Received June 12, 2014

    Report

    Report Number
    9614546-2014-00157
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 20, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4) - EXPLANT OF INTRAOCULAR LENS AND UNEXPECTED POST-OP REFRACTION. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS (IOL) WAS RETURNED TO THE MANUFACTURER. VISUAL INSPECTION REVEALED THAT THE LENS WAS CUT INTO THREE PIECES. ONE HAPTIC WAS CUT IN THE MIDDLE AND PART OF IT WAS MISSING. ALSO, THE SAMPLE HAS RESIDUALS (DEBRIS/PARTICLES) COMPATIBLE WITH HANDLING THE LENS OUT OF STERILE ENVIRONMENT AND THE EXPLANT PROCESS. THE DIOPTER MEASUREMENT WAS UNABLE TO BE PERFORMED DUE TO THE CONDITION OF THE LENS RETURNED (LENS WAS CUT IN THREE PARTS). MANUFACTURING RECORDS WERE REVIEWED. ALL PROCESS OPERATIONS WERE IN COMPLIANCE WITH MANUFACTURING PROCEDURE SPECIFICATIONS. NO DEVIATION OR NON-CONFORMANCE WAS FOUND RELATED TO THE COMPLAINT TYPE REPORTED. REVIEW OF DIOPTER VERIFICATION RECORDS SHOWED THE IOL MET RELEASE SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    WE RECEIVED A REPORT THAT A PATIENT EXPERIENCED UNEXPECTED POST-OP REFRACTION OF -1.50 DIOPTERS IN THE RIGHT EYE AFTER IMPLANTATION OF AN ZMB00225 INTRAOCULAR LENS (IOL). THE SALES REPRESENTATIVE KNEW ON (B)(6) 2014 OF THE UNEXPECTED POST-OP REFRACTION. IN FOLLOW UP IT WAS LEARNED THAT THE IOL WAS EXPLANTED ON (B)(6) 2014. THE IOL WAS CUT INTO FOUR PIECES TO REMOVE IT FROM THE PATIENT''S EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346920 TECNIS 1 MULTIFOCAL MULTIFOCAL IOLS MFK ABBOTT MEDICAL OPTICS ZMB00

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention