BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS 1-PIECE

    MDR report key: 6239943 · Received January 11, 2017

    Report

    Report Number
    2648035-2017-00068
    Event Type
    Malfunction
    Date Received
    January 11, 2017
    Report Date
    April 28, 2017
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE SAMPLE WAS NOT RECEIVED FOR EVALUATION. THE REPORTED ISSUE COULD NOT BE VERIFIED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORD AND COMPLAINT HISTORY REVIEW COULD NOT BE COMPLETED SINCE THE SERIAL NUMBER WAS UNKNOWN. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WERE REVIEWED. THE DFU PROVIDE THE CUSTOMER WITH PROPER USAGE INSTRUCTIONS AND GUIDELINES. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    IF EXPLANTED; GIVE DATE: NA (NOT APPLICABLE) THERE IS NO INDICATION OF EXPLANT. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: IN FOLLOW UP #1 REPORT DATE, AN INCORRECT YEAR (2016) WAS ENTERED IN THE DATE FIELD. THE CORRECT DATE IS 4/26/2017. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THE SURGEON REPORTED THAT THERE WERE TWO CASES WHERE HE HAD A HARD TIME GETTING THE HAPTIC OFF OF THE OPTIC AS JUST GRABBING IT WITH THE CAPSULORHEXIS FORCEPS DID NOT WORK. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS. THIS IS REPORT 1 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25454 TECNIS 1-PIECE MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS ZCB00

    Patients

    Seq Age Sex Outcome Treatment
    1