BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 3182926 · Received June 21, 2013

    Report

    Report Number
    2648035-2013-00255
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 3, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DATE OF IMPLANT: (B)(6) 2013. DATE OF EXPLANT: (B)(6) 2013.

    Additional Manufacturer Narrative · 1

    IT WAS INITIALLY REPORTED ON (B)(6) 2013 THAT THE PATIENT'S ZONULA CILIARIS MIGHT BE LACERATED. FOLLOW-UP INDICATED THAT THE ZONULAR CILIARIS WAS NOT TORN. IT WAS CLARIFIED THAT THE DOCTOR REMOVED THE LENS AND EXPLANTED ANOTHER LENS IN A SECONDARY PROCEDURE ON (B)(6) 2013. SERIAL NUMBER AND EXPIRATION DATE: THE INTRAOCULAR LENS SERIAL NUMBER IS UNKNOWN; THEREFORE, THE EXPIRATION DATE IS UNKNOWN. THE TELEPHONE NUMBER IS UNKNOWN. THE INTRAOCULAR LENS SERIAL NUMBER IS UNKNOWN; THEREFORE, THE MANUFACTURE DATE IS UNKNOWN. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE LENS WENT INTO THE BACK OF THE EYE AND BECAME DISLOCATED. THE LENS WAS THEN EXPLANTED IN A SECONDARY PROCEDURE AND ANOTHER LENS IMPLANTED WITHOUT DIFFICULTY. THE PATIENT VISUAL OUTCOME WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282757 TECNIS 1 MULTIFOCAL MULTIFOCAL IOLS MFK ABBOTT MEDICAL OPTICS ZMB00

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention