BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELLIPS FX PHACO HANDPIECE

    MDR report key: 7057577 · Received November 24, 2017

    Report

    Report Number
    3006695864-2017-01181
    Event Type
    Injury
    Date Received
    November 24, 2017
    Date of Event
    September 14, 2017
    Report Date
    May 10, 2018
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQC
    UDI-DI
    05050474537132
    PMA / PMN Number
    K060366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PHYSIOL IOL, ALCON VISCOELASTICS, I/A HANDPIECE. INITIAL REPORTER TELEPHONE: (B)(\6). (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE SPECIALIST TESTED ALL THE ACCOUNT¿S PHACOEMULSIFICATION HANDPIECES. VISUAL INSPECTION FOUND NONE OF HAVE ANY APPARENT DEFECT. THE HANDPIECES WERE FOUND TO BE WORKING PROPERLY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    IN FOLLOW-UP #2 THE DEVICE MANUFACTURING DATE WAS KNOWN HOWEVER WAS INADVERTENTLY NOT INCLUDED. THE DATE OF MANUFACTURE AS PROVIDED BY THE MANUFACTURING SITE IS 6/2016. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE SURGERY CENTER SUSPECTS A DETERGENT PRODUCT (NONE OF OUR PRODUCT) IS DAMAGING THE HANDPIECES I/A (IRRIGATION/ASPIRATION), THIS PRODUCT WOULD ATTACK THE INTEGRITY OF THE HANDPIECE AND WOULD GENERATE RELEASES OF CHEMICAL MATERIAL (METAL COMPOUNDS OF THE PART OF IA). CONCOMITANT MEDICAL PRODUCTS: ADDITIONAL INFORMATION: IRRIGATION/ASPIRATION HANDPIECE MODEL OM055002. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS PROVIDED FROM THE SURGERY CENTER INDICATING THAT TOXIC ANTERIOR SEGMENT SYNDROME (TASS) WAS CONFIRMED AND NOT ENDOPHTHALMITIS AS PREVIOUS REPORTED. THE HOSPITAL SWITCHED DETERGENT IN (B)(6) 2017 (NO MORE PRECISIONS) FOR ENZYMEX L9 FOR THEIR CLEANING AND STERILIZATION PROCESS OF EQUIPMENT. THE HOSPITAL INDICATED AT THE TIME OF THE EVENT, REUSABLE TIPS WERE USED AND SINCE THE EVENT, DISPOSABLE TIPS ARE BEING USED. THE HOSPITAL CONCLUDED CASES OF TASS FOLLOWING ANALYSES CARRIED OUT ON THE SURGICAL EQUIPMENT USED IN THESE INTERVENTIONS (INCLUDING OUR PHACOEMULSIFICATION MATERIAL). THE HOSPITAL DID NOT SEND THE TEST RESULTS. THE HOSPITAL CONCLUDED THE IRRIGATION AND ASPIRATION(I/A) TIPS WOULD HAVE CONTAINED A SMALL QUANTITY OF ENZYMEX L9 INSIDE THE VERY THIN TIPS AND THEN WOULD HAVE REJECTED SOME CLEANSER/DETERGENT STRAIGHT TO THE EYES OF THE PATIENTS, DURING THE SURGERY. THE HOSPITAL INDICATED DURING THE DISINFECTION OF THE MATERIALS PRIOR INTERVENTION, THE PHACO HANDPIECES AS WELL AS THE I/A TIPS ARE IMMERSED INTO A BATH OF ENZYMEX L9 AND THEN WASHED AND AUTOCLAVED WHILE FOLLOWING THE STRICT PROCEDURES. HOWEVER, DURING THE WASH OF THE MATERIALS AND MORE SPECIFICALLY REGARDING THE I/A TIPS (B)(4), IT HAS BEEN NOTICED THAT THE HOSPITAL WASN¿T USING THE SPECIFIC PLASTIC FLUME ALLOWING TO WASH DIRECTLY INSIDE THE CANNULAS; WHEN WASHING THE EQUIPMENT AND MORE SPECIFICALLY I/A, (B)(4), THE FACILITY DID NOT PUT SPECIFIC NOZZLES TO WASH DIRECTLY INSIDE THE CANNULAS. SINCE THE END OF SEPTEMBER 2017, NO MORE CASES HAVE BEEN REPORTED BY THE HOSPITAL. SINCE THIS PERIOD, THE HOSPITAL HAS PERFORMED 2 CHANGES. FIRST, THE HOSPITAL CLEANS INSIDE THE (B)(4) WHILE USING A DEDICATED SYSTEM AND SECONDLY, SOME SURGEONS ARE NOW USING DISPOSABLE TIPS AND HANDLES. A RECORD REVIEW WAS PERFORMED. A PRODUCT DEFICIENCY REVIEW WAS PERFORMED AND THERE IS NO PRODUCT DEFICIENCY IDENTIFIED. THE RISK MANAGEMENT FILES AND TRENDING WAS REVIEWED. THERE IS NOT A RECOGNIZABLE ADVERSE TREND. THE RISKS AND MITIGATIONS ASSOCIATED WITH THE COMPLAINT ISSUE ARE IDENTIFIED IN EXISTING RISK DOCUMENTS AND NO NEW RISKS WERE IDENTIFIED AS PART OF THIS INVESTIGATION. THE REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR ELLIPS FX PHACO HANDPIECE SHOWED THAT THERE WERE NO ISSUES OR NON-CONFORMITIES. MANUFACTURING HAS BEEN RULED OUT AS A POTENTIAL CAUSE FOR THE REPORTED ISSUE. NO CONCLUSIVE EVIDENCE IDENTIFIED FOR REPORTED ISSUE. THE SYSTEM WAS WORKING WITHIN AMO SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    A HOSPITAL REPORTED A CATARACT PATIENT PRESENTED WITH ENDOPHTHALMITIS OR TOXIC ANTERIOR SEGMENT SYNDROME (TASS) AND A DECREASE IN VISUAL ACUITY USING A PHACOEMULSIFICATION HANDPIECE AT A 2 DAY POST OP EXAM. A DESCRIPTION FROM THE HOSPITAL INDICATED THE INITIAL CATARACT PROCEDURE WAS ON (B)(6) 2017 AND NO COMPLICATIONS WERE NOTED. THE PATIENT WAS RE-HOSPITALIZED DUE TO SUSPICION OF ENDOPHTHALMITIS OR TASS. THERE WAS A REACTION OF THE ANTERIOR CHAMBER WITHOUT HYALITE. THE PATIENT EXPERIENCED A DECREASE OF VISUAL ACUITY OF 4/10 AT A 2 DAY POST OP EXAM. THE PATIENT¿S VISUAL ACUITY AT ONE POINT WAS AT 7/10. THE PATIENT HAS RECOVERED PROGRESSIVELY TO COUNT FINGERS TO 2/10. THE PATIENT WAS TREATED WITH INTRAVENOUS (IVT) VANCOMYCINE, FORMTUM, AND DEXAMETHASONE (ATB- ANTIBIOTIC THERAPY), AND CORTICOTHERAPY. THE ACTIONS THAT THE HOSPITAL HAS TAKEN ARE TO USE IRRIGATION AND ASPIRATION SINGLE USE. THE SURGERY CENTER INDICATED THE PHACO HANDPIECES (ABBOTT) WERE TREATED ACCORDING TO THE WASHING PROTOCOL IN FORCE AT THE GHEM STERILIZATION UNIT, ENZYMEX L9 PRE-DISINFECTION, WASH WITH MEDICLEAN THEN STERILIZE AT 134 ° C 18 MIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836852 ELLIPS FX PHACO HANDPIECE PHACO HANDPIECE HQC ABBOTT MEDICAL OPTICS 690880 05050474537132

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R