BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 2891920 · Received December 31, 2012

    Report

    Report Number
    9614546-2012-00218
    Event Type
    Injury
    Date Received
    December 31, 2012
    Date of Event
    October 11, 2010
    Report Date
    December 13, 2012
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P080010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS (IOL) WAS RETURNED TO THE MANUFACTURER. VISUAL INSPECTION SHOWED A LENS WHERE THE OPTIC WAS CUT IN HALF, NO OPTICAL DEVIATIONS ON THE OPTIC PARTS COULD BE FOUND. DUE TO THE CONDITION OF THE RETURNED SAMPLE, A DIOPTER MEASUREMENT COULD NOT BE PERFORMED.CONCLUSION: THE IOL PASSED ALL ACCEPTANCE CRITERIA FOR ALL TESTS PERFORMED AND WAS WITHIN ALL SPECIFICATIONS DURING THE MANUFACTURING PROCESS, THEREFORE NO PRODUCTION RELATED CAUSE IS EXPECTED.(B)(4): PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    (B)(4).PRIOR TO RELEASE TO MARKET THE INTRAOCULAR LENS MET ALL MANUFACTURING SPECIFICATIONS.(B)(4): PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING SYMPTOMS OF BLURRINESS AFTER IMPLANTATION OF THE INTRAOCULAR LENS (IOL). IT WAS STATED THAT A YAG CAPSULOTOMY WAS PERFORMED TO REDUCE THE SYMPTOMS EXPERIENCED BY THE PATIENT. IT WAS REPORTED THAT THE YAG CAPSULOTOMY PROVED UNHELPFUL AND THE LENS WAS EXPLANTED. NO COMPLICATIONS WERE REPORTED. PATIENT WAS STATED TO BE DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TECNIS MULTIFOCAL IOLS MFK ABBOTT MEDICAL OPTICS ZMA00

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention