BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 2210509 · Received August 12, 2011

    Report

    Report Number
    2648035-2011-00172
    Event Type
    Injury
    Date Received
    August 12, 2011
    Report Date
    July 13, 2011
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P99080
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND MET ALL SPECIFICATIONS. NO ADDITIONAL REPORTS OF A SIMILAR NATURE WERE RECEIVED FOR THE REMAINING LENSES IN THIS PRODUCTION ORDER. THE RESULTS OF OUR INVESTIGATION DO NOT SUGGEST THE LENS CAUSED OR CONTRIBUTED TO THIS ADVERSE EVENT. FURTHER INVESTIGATION CONFIRMS THE LENSES WERE MANUFACTURED IN SEVEN SEPARATE PRODUCTION ORDERS AND NOT FIVE AS INITIALLY REPORTED. ALL PERTINENT INFORMATION AVAILABLE TO AMO HAS BEEN SUBMITTED. SHOULD NEW INFORMATION BE RECEIVED THAT CHANGES THE FACTS AND/OR CONCLUSION OF THIS REPORT, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER'S INVESTIGATION IS ONGOING AND REMAINS INCONCLUSIVE AT THIS TIME. THE REPORTED INTRAOCULAR LENSES (IOLS) MET ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. A REVIEW OF THE SERIAL NUMBERS, AS REPORTED TO THE MANUFACTURER, CONFIRMS THE SEVEN INTRAOCULAR LENSES ASSOCIATED WITH THESE EVENTS WERE MANUFACTURED IN FIVE DIFFERENT MONTHS, 3 DIFFERENT YEARS AND IN FIVE SEPARATE PRODUCTION ORDERS. OUR INVESTIGATION TO DATE SUGGESTS THE IOLS DID NOT MALFUNCTION NOR CAUSE OR CONTRIBUTE TO THE ADVERSE EVENTS REPORTED. ALL PERTINENT INFORMATION AVAILABLE TO AMO HAS BEEN SUBMITTED. SHOULD NEW INFORMATION THAT CHANGES THE FACTS AND/OR CONCLUSION OF THIS REPORT, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. IOLS REMAIN IMPLANTED.

    Description of Event or Problem · 1

    ONE SURGEON REPORTED SEVEN CASES OF (TASS) TOXIC ANTERIOR SEGMENT SYNDROME OCCURRING AT ONE SURGERY CENTER. THESE EVENTS OCCURRED IN TWO DIFFERENT WEEKS FOLLOWING CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANT. FOUR CASES OCCURRED IN ONE WEEK AND THREE IN THE FOLLOWING WEEK. THE DATES FOR THESE EVENTS ARE UNKNOWN. AN UNIDENTIFIED NUMBER OF THE SEVEN PATIENTS WERE TREATED WITH TOPICAL STEROIDS AND ONE PATIENT REQUIRED A VITRECTOMY. ALL SEVEN INTRAOCULAR LENSES WERE IMPLANTED BY THE SAME SURGEON AND NONE WERE EXPLANTED. THE SURGERY CENTER IS INVESTIGATING ALL PROCESSES, STERILIZERS, CLEANING METHODS AND PRODUCTS USED DURING THESE SURGERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TECNIS MONOFOCAL INTRAOCULAR LENS HQL ABBOTT MEDICAL OPTICS ZA9003

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention