BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS CL

    MDR report key: 2795418 · Received October 17, 2012

    Report

    Report Number
    2648035-2012-00309
    Event Type
    Injury
    Date Received
    October 17, 2012
    Date of Event
    September 25, 2012
    Report Date
    October 1, 2012
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P880081
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS OF MANUFACTURING RECORD REVIEW: THE REVIEW OF THE DOCUMENTATION AND TESTING PRESENTED IN THE MANUFACTURING RECORD WERE FOUND WITHIN PRODUCT SPECIFICATIONS. THE DOCUMENTATION SHOWS THAT THE PRODUCTION ORDER WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. NO DEVIATION OR NONCONFORMANCE WAS GENERATED. RECORD REVIEW INCLUDED: RAW MATERIAL RECORDS, PROCESS AND/OR MATERIAL CHANGES, ENVIRONMENTAL AND STERILIZATION. STERILIZATION RECORDS: THE STERILIZATION RECORD FOR THIS LOT WAS REVIEWED AND NO DEVIATION WAS FOUND DURING THE STERILIZATION CYCLE. THE DOCUMENTATION SHOWS THE FOLLOWING RESULTS: THE STERILITY TEST COMPLETED AND NO GROWTH CERTIFIED. PYROGEN TEST COMPLETED AND NON-PYROGENICITY CERTIFIED. EO CYCLE PARAMETER MET. AERATION PARAMETERS MET CONCLUSIONS: THE DOCUMENTATION SHOWS THAT THE PRODUCTION ORDER WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS INC HAS BEEN PROVIDED.

    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

    REPORTEDLY, THE PATIENT EXPERIENCED POST OPERATIVE INFECTION. A CULTURE PRODUCED GRAM POSITIVE (+) (B)(6). IT WAS STATED THAT THE SURGICAL CENTER NEEDED TO RULE OUT ALL POSSIBLE CAUSES OF THIS INFECTION. IN ADDITION, IT WAS REPORTED THAT THERE COULD HAVE BEEN A POSSIBLE BREACH IN STERILE TECHNIQUE, WHICH THE SURGICAL CENTER IS STILL INVESTIGATING. NO COMPLICATIONS WERE REPORTED DURING SURGERY. PATIENT IS REPORTED TO BE DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED. THE IMPLANT DATE WAS (B)(6) 2012; HOWEVER, THE ACTUAL DATE THE INFECTION WAS DIAGNOSED WAS NOT SPECIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TECNIS CL MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS Z9002

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention