BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 3232614 · Received July 18, 2013

    Report

    Report Number
    9614546-2013-00122
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 27, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: PATIENT EXPERIENCED DEBILITATING SYMPTOMS AFTER THE LENS WAS IMPLANTED ON (B)(6) 2013. THE PATIENT WAS REFERRED TO A RETINA SPECIALIST FOR A SECOND OPINION PRIOR TO HAVING THE EXPLANT PERFORMED. FURTHER IT WAS STATED BY THE IMPLANTING PHYSICIAN THAT THE PATIENT WAS NOW DOING FINE POST EXPLANT AND HAS 20/20 VISION. NO ADDITIONAL INFORMATION WAS PROVIDED. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THE BATCH HAS PASSED ALL ACCEPTANCE CRITERIA FOR ALL TESTS PERFORMED AND WAS WITHIN ALL SPECIFICATIONS. THE DEVICE MANUFACTURING RECORDS SHOWED NO DEVIATIONS. THE DIOPTER MEASUREMENT RECORDS WERE VERIFIED AND WERE SHOWN TO BE WITHIN SPECIFICATIONS. THIS WAS IN COMPLIANCE WITH THE LABELED DIOPTRIC POWER OF 22.5 DIOPTER FOR THIS SERIAL NUMBER. CORRECTED DATA: EXPIRATION DATE: 05/04/2015. DEVICE MANUFACTURE DATE: 06/04/2012. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS (IOL) WAS RETURNED FOR INSPECTION. VISUAL INSPECTION SHOWED A LENS WHERE THE OPTIC WAS CUT IN HALF. NO OPTICAL DEVIATIONS ON THE RECEIVED OPTIC PARTS COULD BE FOUND. DIOPTER VERIFICATION COULD NOT BE PERFORMED DUE TO THE CONDITION OF THE LENS RECEIVED. THE CONDITION OF THE LENS RECEIVED IS A RESULT OF THE EXPLANT PROCESS AND NOT THE CONDITION OF THE LENS WHEN IT WAS USED IN THE PATIENT. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT EXPLANT OF THE INTRAOCULAR LENS (IOL) PLACED IN HIS LEFT EYE (OS) DUE TO "PATIENT NOT BEING ABLE TO SEE ANYTHING." REPORTEDLY, THERE WERE NO COMPLICATIONS ASSOCIATED WITH THE PROCEDURE, NO INCISION ENLARGEMENT OR VITRECTOMY PERFORMED. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED AFTER THE IOL WAS EXCHANGED. PATIENT WAS NOTED TO BE HAPPY WITH THE REPLACEMENT MONOFOCAL LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334595 TECNIS 1 MULTIFOCAL MULTIFOCAL IOLS MFK ABBOTT MEDICAL OPTICS ZMB00

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention