BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 2951195 · Received February 8, 2013

    Report

    Report Number
    9614546-2013-00013
    Event Type
    Injury
    Date Received
    February 8, 2013
    Date of Event
    January 2, 2013
    Report Date
    January 22, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MANUFACTURING RECORD REVIEW CONCLUDED THAT THE DEVICE MANUFACTURING RECORDS WERE REVIEWED AND SHOWED NO DEVIATIONS. IN ADDITION, THE DIOPTER MEASUREMENT RECORDS FOR THIS PARTICULAR LENS WAS VERIFIED AND SHOWN TO BE WITHIN SPECIFICATIONS. IN CONCLUSION, THE BATCH HAS PASSED ALL ACCEPTANCE CRITERIA FOR ALL TESTS PERFORMED AND IS WITHIN ALL SPECIFICATIONS. PRIOR TO RELEASE TO MARKET THE INTRAOCULAR LENS MET ALL MANUFACTURING SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REMOVAL AND EXCHANGE OF AN INTRAOCULAR LENS (IOL) IN A SECONDARY PROCEDURE DUE TO EXPERIENCING SYMPTOMS OF POOR VISION. IT WAS STATED THAT THERE WAS NO INCISION ENLARGEMENT DURING THE EXPLANT, AND NO COMPLICATIONS WERE REPORTED. PATIENT STATED TO BE DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53637 TECNIS 1 MULTIFOCAL MULTIFOCAL IOLS MFK ABBOTT MEDICAL OPTICS ZMB00

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention