BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 2874364 · Received December 14, 2012

    Report

    Report Number
    9614546-2012-00205
    Event Type
    Injury
    Date Received
    December 14, 2012
    Date of Event
    December 5, 2012
    Report Date
    December 6, 2012
    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

    THE INTRAOCULAR LENS (IOL) WAS RETURNED TO THE MANUFACTURER FOR VISUAL INSPECTION. VISUAL INSPECTION SHOWED A LENS WERE THE OPTIC WAS CUT IN HALF, NO OPTICAL DEVIATIONS ON THE OPTIC PARTS COULD BE FOUND. CONCLUSION: THE IOL PASSED ALL ACCEPTANCE CRITERIA FOR ALL TESTS PERFORMED AND WAS WITHIN ALL SPECIFICATIONS DURING THE MANUFACTURING PROCESS. MANUFACTURING RECORD REVIEW: - THE DEVICE MANUFACTURING RECORDS WERE REVIEWED AND SHOWED NO DEVIATIONS. DIOPTER MEASUREMENT RECORDS FROM THIS PARTICULAR LENS WAS VERIFIED AND SHOWED TO BE WITHIN SPECIFICATIONS. THIS IS IN COMPLIANCE WITH THE LABELED DIOPTRIC POWER 15.0 DIOPTER FOR THIS LOT. REVIEW OF THE HISTORICAL COMPLAINT DATA BASE REVEALED THAT NO SIMILAR COMPLAINTS FROM THIS LOT NUMBER WERE RECEIVED. CONCLUSION: THE BATCH HAS PASSED ALL ACCEPTANCE CRITERIA FOR ALL TESTS PERFORMED AND IS WITHIN ALL SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    SECTION F COMPLETED BY THE MANUFACTURER.(B)(4).ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. (B)(4): PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    (B)(4).ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. (B)(4): PLACEHOLDER.

    Description of Event or Problem · 1

    WE RECEIVED A REPORT FROM A PHYSICIAN WHO EXPLANTED AN INTRAOCULAR LENS (IOL) BECAUSE THE PATIENT WAS UNHAPPY WITH THE VISUAL OUTCOME AND WAS UNCOMFORTABLE.

    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 65 YR Required Intervention