BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 3556175 · Received January 6, 2014

    Report

    Report Number
    9614546-2014-00001
    Event Type
    Injury
    Date Received
    January 6, 2014
    Date of Event
    October 23, 2013
    Report Date
    December 26, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P990080
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CORRECTED DATE OF EVENT IS (B)(6) 2013. THE CORRECTED IMPLANT DATE IS (B)(6) 2013. THE CORRECTED EXPLANT DATE IS (B)(6) 2013. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: THE CORRECTED DATE OF REPORT IS (B)(6) 2013. ADDITIONAL INFORMATION: BASED ON THE MANUFACTURING RECORD REVIEW, THERE WERE NO NONCONFORMANCES. THERE WERE NO ASSOCIATED NONCONFORMITY MATERIAL REPORTS. THERE WERE NO DEVIATIONS WITHIN THE PRODUCTION ORDER. THE DEVICE HISTORY RECORD INDICATED THAT THERE WERE NO NONCONFORMANCES. THERE WERE NO NONCONFORMANCES WITH RESPECT TO THE STERILIZATION PROCESS. THERE WERE NO PROCESS AND/OR MATERIAL CHANGES WITHIN THE IDENTIFIED PRODUCTION ORDER NUMBER FOR THE REPORTED LENS. THE MANUFACTURING RECORD REVIEW INDICATED THAT THE PRODUCT MET MANUFACTURING RELEASE CRITERIA. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    PMA/510 (K) #: P980040. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    WE RECEIVED A REPORT THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE AFTER SHE EXPERIENCED UNEXPECTED POST-OPERATIVE REFRACTION. THERE WERE NO SURGICAL COMPLICATIONS, SUCH AS AN INCISION ENLARGEMENT OR VITRECTOMY. THE SURGEON INDICATED THAT THERE WAS NO QUALITY PROBLEM WITH THE IOL, HE SELECTED THE WRONG DIOPTER LENS. THE IOL WAS DISCARDED IN THE FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6067 TECNIS 1 MULTIFOCAL MULTIFOCAL IOLS MFK ABBOTT MEDICAL OPTICS ZMB00

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention