BEUDAMED
    FDA Adverse Event Death Summary report: N

    TECNIS

    MDR report key: 1666297 · Received April 25, 2010

    Report

    Report Number
    2648035-2010-00055
    Event Type
    Death
    Date Received
    April 25, 2010
    Date of Event
    March 13, 2010
    Report Date
    March 25, 2010
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P99080/S06
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LENS WAS NOT EXPLANTED AND THEREFORE NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE ATTENDING PHYSICIAN STATED HE WAS UNSURE IF THIS EVENT WAS ASSOCIATED WITH THE INTRAOCULAR LENS IMPLANT FROM TWO MONTHS PRIOR. THE INFECTION CONTROL PHYSICIAN REVIEWED THE CASE FOR CAUSALITY AND DETERMINED THE IOL WAS NOT THE CAUSE. IN HIS OPINION, THE MOST LIKELY SITE OF ENTRY FOR THE BACTERIA WAS THE INCISION MADE DURING THE INITIAL IMPLANT SURGERY. OUR REVIEW OF THE COMPLETE MANUFACTURING RECORDS FOR THIS INTRAOCULAR LENS (IOL) SHOWED NO DEVIATIONS OR NON-CONFORMITIES DURING THE PROCESS THAT WOULD CAUSE AN INFECTIOUS REACTION. BASED ON OUR INVESTIGATION, WE THEREFORE CONCLUDED THAT THE IOL REPORTED IN THIS COMPLAINT DID NOT CAUSE THIS ADVERSE EVENT.

    Description of Event or Problem · 1

    A TELEPHONE CALL WAS RECEIVED FROM THE INFECTION CONTROL PRACTITIONER AT THE HOSPITAL REPORTING THAT A FEMALE PATIENT WITH A PAST HISTORY OF (B) (6) WAS IMPLANTED WITH AN INTRAOCULAR LENS IN JANUARY. APPROXIMATELY TWO MONTHS LATER, THE PATIENT WAS DIAGNOSED WITH PNEUMONIA AND GIVEN ANTIBIOTICS. WITHIN SIX HOURS OF TAKING THE MEDICATION SHE DEVELOPED FACIAL SWELLING AND POOR ORAL INTAKE. FIVE DAYS LATER, THE PATIENT PRESENTED AT THE HOSPITAL'S EMERGENCY ROOM AND WAS DIAGNOSED WITH NECROTIZING FASCIITIS. A CT SCAN REVEALED AIR POCKETS IN THE MASTICATOR SPACE WITH NECROTIZING INFECTION. SHE UNDERWENT SURGERY ON FOUR CONSECUTIVE DAYS FOR DEBRIDEMENT OF THE PARAPHARYNGEAL SPACE, RIGHT LIP, FACE AND PAROTID AREA. CULTURES TAKEN FROM THE DRAINAGE REVEALED (B) (6). SEPTIC SHOCK DEVELOPED AND SHE WAS TREATED WITH SEVERAL ANTIBIOTICS AND AN ANTI-FUNGAL DRUG. THE PATIENT WAS NON-RESPONSIVE TO TREATMENT AND EXPIRED ON THE FOURTH DAY OF HOSPITALIZATION. THE HOSPITAL IS INVESTIGATING ALL PRODUCTS USED DURING THE IMPLANT PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death| H| L| R| S CLINDAMYCIN| FLUCONAZOLE| VANCOMYCIN| ZOSYN