BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 2882679 · Received December 20, 2012

    Report

    Report Number
    9614546-2012-00209
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    September 27, 2012
    Report Date
    December 12, 2012
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING RECORD REVIEW CONCLUDED THAT THE BATCH SHOWED NO DEVIATIONS, AND THE DIOPTER MEASUREMENT RECORDS FROM THIS PARTICULAR LENS WAS CONCLUDED TO BE WITHIN ALL SPECIFICATIONS. SECTION F COMPLETED BY MANUFACTURER. (B)(4). (B)(6). PRIOR TO RELEASE TO MARKET THE INTRAOCULAR LENS MET ALL MANUFACTURING SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA SECTION: (B)(6) 2012. EXPIRATION DATE:06/30/2016. (B)(4). PLACEHOLDER.

    Description of Event or Problem · 1

    A PATIENT REPORTED THAT SHE WAS EXPERIENCING SIGNIFICANT GLARE AFTER AN INTRAOCULAR LENS (IOL) WAS IMPLANTED. SHE SAW HER PHYSICIAN AND ON (B)(6) 2012. THE IOL WAS REPOSITIONED. IN FOLLOW UP WITH THE PHYSICIAN, IT WAS STATED THAT THE PATIENT NOTICED SIGNIFICANT IMPROVEMENT IN VISION AND IS DOING WELL. NO COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention