BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS MULTIFOCAL

    MDR report key: 1945117 · Received January 3, 2011

    Report

    Report Number
    9614546-2010-00074
    Event Type
    Injury
    Date Received
    January 3, 2011
    Date of Event
    December 7, 2010
    Report Date
    December 8, 2010
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P080010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - THE INTRAOCULAR LENS WAS RECEIVED AND IS CURRENTLY BEING EVALUATED AT THE MANUFACTURING SITE. THE IOL MET ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. AN UPDATE TO THIS REPORT WILL BE SUBMITTED FOLLOWING ANALYSIS OF THE IOL. ALL INFORMATION AVAILABLE IS INCLUDED IN THIS REPORT.

    Additional Manufacturer Narrative · 1

    THE RETURNED IOL WAS EVALUATED AT THE MANUFACTURING SITE. VISUAL INSPECTION OF THE LENS SHOWED NO OPTICAL DEVIATIONS. THE DIOPTER WAS MEASURED AND CONFIRMED TO BE CORRECT AS LABELED, 19.0 D. BATCH RECORDS WERE REVIEWED AND SHOWED NO DEVIATIONS. A REVIEW OF THE HISTORICAL COMPLAINT DATA BASE REVEALED THAT NO ADDITIONAL COMPLAINTS FROM THIS LOT NUMBER WERE RECEIVED. OUR INVESTIGATION IDENTIFIED NO PRODUCT DEFICIENCY, SUGGESTING THAT THIS EVENT WAS NOT CAUSED BY THE IOL. ALL AVAILABLE INFORMATION IS INCLUDED IN THIS REPORT.

    Description of Event or Problem · 1

    DURING BAXTER'S REVIEW OF THE EVENT HISTORY FOR ANOTHER REPORT, IT WAS DISCOVERED THAT FAILURE (B)(4) OCCURRED, WHICH CAUSED AN INTERRUPTION DURING DELIVERY. THERE WAS NO ADVERSE EVENT, PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. THERE IS NO FURTHER COMPLAINT INFORMATION AVAILABLE. THE USER INTERFACE MODULE MASTER SOFTWARE VERSION IS 5.09.90, CATEGORIZED AS REMEDIATED.

    Description of Event or Problem · 1

    PHYSICIAN REPORTED THE INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO A REFRACTIVE SURPRISE. THE LENS WAS REMOVED AND REPLACED 2 MONTHS AFTER THE INITIAL IMPLANT WITHOUT COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TECNIS MULTIFOCAL MULTIFOCAL IOL MFK ABBOTT MEDICAL OPTICS ZM900

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention