BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 3163609 · Received June 11, 2013

    Report

    Report Number
    9614546-2013-00093
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    September 10, 2012
    Report Date
    May 21, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: EVENT DATE: (B)(6) 2012. REPORT DATE: 05/16/2013. CLARIFICATION: SECONDARY PROCEDURE (ATTEMPTED EXPLANT) WAS PERFORMED ON (B)(6) 2012 BUT IT IS UNKNOWN IF THE INTRAOCULAR LENS WAS EXPLANTED. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE MANUFACTURING RECORDS WERE REVIEWED AND SHOWED NO DEVIATIONS. DIOPTER MEASUREMENT RECORDS FROM THIS PARTICULAR LENS WERE VERIFIED AND SHOWN TO BE WITHIN SPECIFICATIONS. THIS IS IN COMPLIANCE WITH THE LABELED DIOPTRIC POWER 20.0 DIOPTER FOR THIS PRODUCTION ORDER. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: DATE OF EVENT: (B)(6) 2012. INTRAOCULAR LENS WAS BEING EXPLANTED BECAUSE PATIENT COMPLAINED OF BLURRY VISION AND DIFFICULTY WITH NEAR VISUAL ACUITY. FOLLOW UP WITH SURGEON INDICATED THE PATIENT DID NOT DIE DURING THE EXPLANT PROCEDURE. HYPERTENSION AND DIABETES. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT IMPLANTATION OF AN INTRAOCULAR LENS (IOL) WHICH REQUIRED AN EXPLANT IN A SECONDARY PROCEDURE. IT WAS STATED THAT THE IMPLANTING SURGEON ATTEMPTED TO EXPLANT THE LENS; HOWEVER, WAS UNABLE TO AND THE PATIENT WAS INFORMED TO GO TO (B)(6). IT IS UNCLEAR IF THE PATIENT PROCEEDED WITH LENS EXPLANTATION OR IF THE INTRAOCULAR LENS (IOL) IS STILL IMPLANTED. IT WAS STATED THAT THE PATIENT IS NOW DECEASED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263676 TECNIS 1 MULTIFOCAL MULTIFOCAL IOLS MFK ABBOTT MEDICAL OPTICS ZMB00

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention