BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 2832619 · Received November 14, 2012

    Report

    Report Number
    9614546-2012-00192
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    October 11, 2012
    Report Date
    November 8, 2012
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE PATIENT WAS LAST SEEN BY HER RETINAL SURGEON ON (B)(6) 2012 AND WAS STATED TO BE DOING WELL. THE PATIENT'S PRIMARY CARE DOCTOR REPORTED THAT HE DOES NOT THINK THE INFECTION WAS RELATED TO THE INTRAOCULAR LENS IMPLANT, BUT RATHER THE POSSIBILITY OF A FIBER FROM THE SURGICAL GOWN. (B)(4). A REVIEW OF THE MANUFACTURING RECORDS WERE REVIEWED AND SHOWED NO DEVIATIONS. BATCH RECORDS WERE REVIEWED AND SHOWED NEITHER DEVIATIONS REGARDING THE STERILIZATION PROCESS NOR DEVIATIONS REGARDING THE STERILITY TEST RESULTS. THE SPORE STRIPS AND TSB MEDIUM USED FOR THE STERILITY TEST WERE VERIFIED AND SHOWED NO DEVIATIONS. ENVIRONMENTAL CONTROL CONDITIONS DURING THE MANUFACTURING PERIOD WERE VERIFIED WITH RESPECT TO BIOBURDEN AND PYROGENS AND SHOWED NO DEVIATIONS. THE DIOPTER MEASUREMENT RECORDS WERE VERIFIED AND SHOWED TO BE WITHIN SPECIFICATIONS. THIS WAS IN COMPLIANCE WITH THE LABELED DIOPTRIC POWER OF 15.0 DIOPTER FOR THIS LENS. THE BATCH PASSED ALL ACCEPTANCE CRITERIA FOR ALL TESTS PERFORMED AND WAS WITHIN ALL SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). PRIOR TO RELEASE TO MARKET THE INTRAOCULAR LENS MET ALL MANUFACTURING SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS ENDOPHTHALMITIS OF THE LEFT EYE AFTER IMPLANTATION OF A ZMB00 INTRAOCULAR LENS (IOL). A RAPID ONSET OF ENDOPHTHALMITIS WAS SEEN POST OPERATIVE DAY 1. PATIENT WAS PRESCRIBED MEDICATION AND IS NOTED TO BE IMPROVING FROM HER SYMPTOMS. THE INTRAOCULAR LENS (IOL) IS STILL IMPLANTED. CULTURES WERE DONE AND PRODUCED NEGATIVE (-) GROWTH OF ORGANISMS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention