BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 3232571 · Received July 18, 2013

    Report

    Report Number
    2648035-2013-00293
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    May 14, 2013
    Report Date
    June 25, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    FOLLOW UP FROM THE LOCATION CONTACT CLARIFIED THAT THE PATIENT COULD NOT ADAPT TO MULTIFOCALITY. THE INTRAOCULAR LENS WAS EXPLANTED AND A MONOFOCAL LENS WAS IMPLANTED. THE PATIENT IS REPORTED TO BE DOING EXCELLENT, WITH GOOD DISTANCE VISION AND WEARING READING GLASSES FOR NEAR. MANUFACTURING RECORDS WERE REVIEWED. DEVICE MANUFACTURING RECORD WAS REVIEWED WITH THE FOLLOWING RESULTS: ALL PROCESS OPERATIONS PRESENTED IN THE MANUFACTURING RECORD FROM GENERATION TO BOXING WERE IN COMPLIANCE WITH MANUFACTURING INSTRUCTIONS SPECIFICATIONS. ALL TESTS RESULTS SHOWED A PASS CONDITION. NO DEVIATION OR NONCONFORMANCE (NCR) RELATED TO THE CUSTOMER CLAIM WAS GENERATED. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS (IOL) WAS RETURNED TO THE MANUFACTURER. VISUAL EXAMINATION OF THE DEVICE FOUND THAT IT HAD BEEN CUT IN HALF AND BOTH HAPTICS WERE MISSING. A FEW LOOSE PARTICLES WERE OBSERVED IN THE OPTIC ZONE COMPATIBLE WITH HANDLING THE LENS OUT OF THE STERILE ENVIRONMENT. INSPECTION AT 10X MAGNIFICATION CONFIRMED THE LENS TO BE A ZMB00 MODEL. THE CONDITION OF THE RETURNED LENS IS CONSISTENT WITH ONE THAT HAS BEEN IMPLANTED AND EXPLANTED FROM A PATIENT'S EYE. IT ALSO PRECLUDED THE ABILITY TO PERFORM A DIOPTER CHECK. THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    WE RECEIVED A REPORT CONCERNING A PATIENT WHERE THE PATIENT HAD A BILATERAL INTRAOCULAR LENS (IOL)EXPLANT AS SHE WAS NOT ABLE TO ADAPT BILATERALLY. THE INTRAOCULAR LENS WAS REPLACED WITH A MONOFOCAL LENS. NO SUTURES WERE USED AND NO PATIENT INJURY REPORTED. THIS REPORT FOR THE RIGHT EYE; A SEPARATE REPORT IS FILED FOR THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334348 TECNIS 1 MULTIFOCAL MULTIFOCAL IOLS MFK ABBOTT MEDICAL OPTICS ZMB00

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention