BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 6100749 · Received November 14, 2016

    Report

    Report Number
    9614546-2016-00596
    Event Type
    Injury
    Date Received
    November 14, 2016
    Date of Event
    October 25, 2016
    Report Date
    November 14, 2016
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    UDI-DI
    05050474560666
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: PRODUCT TESTING COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED. THEREFORE, REPORTED COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORD REVIEW: DURING THE MANUFACTURING RECORD REVIEW OF THE PRODUCTION ORDER FOR THIS SERIAL NUMBER, NO PRODUCT DEFICIENCY WAS IDENTIFIED. THE DOCUMENTATION SHOWS THAT THE PRODUCTION ORDER WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. A REVIEW OF THE COMPLAINTS RELATED TO THE PRODUCTION ORDER WAS PERFORMED AND THE RESULTS REVEALED NO SIMILAR COMPLAINTS FOR THIS ORDER NUMBER. A HISTORICAL COMPLAINT DATA REVIEW WAS PERFORMED AND RESULTS DID NOT IDENTIFY ANY PRODUCT DEFICIENCY. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WAS REVIEWED. THE DFU ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS FOR THE PROPER USE AND HANDLING OF THE PRODUCT. BASED ON THE MANUFACTURING RECORDS REVIEW, HISTORICAL COMPLAINT REVIEW AND NON-CONFORMANCE/CAPA REVIEW, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A ZLB00 INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE RIGHT EYE (OD) OF A FEMALE PATIENT DUE TO A WRONG POWER LENS WAS IMPLANTED. THE PATIENT'S SYMPTOMS WERE HALOS AND GLARE, VISUAL DISTURBANCE, AND POOR VISUAL QUALITY. THE PATIENT WAS PRE-OP SEQ -0.25 AND POST-OP SEQ +0.75. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751783 TECNIS 1 MULTIFOCAL MULTIFOCAL IOLS MFK ABBOTT MEDICAL OPTICS ZLB00 05050474560666

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention