BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 3885145 · Received June 19, 2014

    Report

    Report Number
    9614546-2014-00162
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 23, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE LENS WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. VISUAL INSPECTION WITH THE UNAIDED EYE SHOWED THAT ONE OF THE HAPTICS WAS DETACHED. VISUAL INSPECTION USING A MICROSCOPE AT 12X MAGNIFICATION SHOWED THE PRODUCT CAN BE IDENTIFIED AS A TECNIS MULTIFOCAL ACRYLIC 1-PIECE INTRAOCULAR LENS BECAUSE OF THE TYPE OF HAPTIC AND THE PRESENCE OF A DIFFRACTIVE RING PATTERN ON THE OPTIC. THE LENS WAS CONTAMINATED WHEREBY DUST PARTICLES WERE PRESENT. THE LENS OPTIC WAS RECEIVED DAMAGED WITH A DEEP SCRATCH ON BOTH SIDES OF THE LENS AND SEVERAL SHALLOW SCRATCHES. THE LENS CONDITION IS CONSISTENT WITH A LENS THAT WAS EXPLANTED FROM THE PATIENT'S EYE. FURTHER ANALYSIS IS NOT POSSIBLE DUE TO THE CONDITION OF THE LENS. THE MANUFACTURING RECORD REVIEW INDICATED THAT THE STERILIZATION BATCH WAS RELEASED WITH NO NONCONFORMANCES. THERE WERE NO PROCESS AND / OR MATERIAL CHANGES WITHIN THE PRODUCTION ORDER NUMBER. REVIEW OF THE MANUFACTURING RECORD SHOWS THAT THE LENS MET MANUFACTURING RELEASE CRITERIA. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT EYE AND WAS EXPLANTED IN A SECONDARY PROCEDURE DUE TO LENS POWER RESULTING IN AN UNEXPECTED POST OPERATIVE REFRACTION. AN INCISION ENLARGEMENT WAS REQUIRED. THE LENS WAS REPLACED WITH A LENS MANUFACTURED BY ANOTHER MANUFACTURER. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361039 TECNIS 1 MULTIFOCAL MULTIFOCAL IOLS MFK ABBOTT MEDICAL OPTICS ZMB00

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention