BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 2993584 · Received March 7, 2013

    Report

    Report Number
    9614546-2013-00046
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    November 29, 2012
    Report Date
    February 15, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE EXPLANTED INTRAOCULAR LENS (IOL) WAS RETURNED TO OUR MANUFACTURING FACILITY FOR EVALUATION. VISUAL INSPECTION SHOWED A LENS WHERE THE OPTIC WAS CUT IN HALF, WHICH IS CONSISTENT WITH A LENS THAT HAS BEEN REMOVED FROM THE EYE. DUE TO THE RECEIVED CONDITION OF THE LENS, DIOPTER MEASUREMENT COULD NOT BE PERFORMED. NO OPTICAL DEVIATIONS ON THE OPTIC PARTS WERE FOUND. THE LENS PASSED ALL ACCEPTANCE CRITERIA FOR ALL TESTS PERFORMED AND WAS WITHIN ALL SPECIFICATIONS DURING THE MANUFACTURING PROCESS. (B)(4): PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    MANUFACTURING RECORD REVIEW REVEALED THAT THE DIOPTER MEASUREMENT RECORDS FROM THIS PARTICULAR LENS WERE VERIFIED AND SHOWN TO BE WITHIN SPECIFICATIONS. THIS IS IN COMPLIANCE WITH THE LABELED DIOPTRIC POWER 22.5 DIOPTER OF THIS LOT NUMBER. IN CONCLUSION, THE BATCH HAS PASSED ALL ACCEPTANCE CRITERIA FOR ALL TESTS PERFORMED AND IS WITHIN ALL SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN IMPLANTATION OF AN INTRAOCULAR LENS (IOL) WHICH WAS EXPLANTED IN A SECONDARY PROCEDURE DUE TO AN UNEXPECTED MYOPIC OUTCOME. IT WAS STATED THAT THERE WAS NO INCISION ENLARGEMENT MADE DURING REMOVAL AND EXCHANGE OF THE LENS. NO COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97001 TECNIS 1 MULTIFOCAL MULTIFOCAL IOLS MFK ABBOTT MEDICAL OPTICS ZMB00

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention