BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELLIPS FX PHACO HANDPIECE

    MDR report key: 16687728 · Received April 6, 2023

    Report

    Report Number
    3012236936-2023-00810
    Event Type
    Injury
    Date Received
    April 6, 2023
    Date of Event
    March 14, 2023
    Report Date
    July 17, 2023
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    HQC
    UDI-DI
    05050474537132
    PMA / PMN Number
    K981116
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: INVESTIGATION WAS COMPLETED AND FOLLOWING WAS ADDED. SECTION H6: TYPE OF INVESTIGATION: 10. FIELD SERVICE ENGINEER (FSE) WAS DEPLOYED AND THERE WAS NO PROBLEM FOUND WITH THE PHACO SYSTEM. THE SAME PHACO HANDPIECE WAS INVOLVED IN 3 CASES, FSE REPLACES PHACO HANDPIECE PREVENTIVELY. NO RELATED DEVIATION, NCMR, NC OR CAPA WAS INITIATED DURING THE MANUFACTURING PROCESS OF THE REPORTED. BASED ON THE INFORMATION OBTAINED, THERE IS NO INDICATION OF PRODUCT MALFUNCTION OR PRODUCT DEFICIENCY. THE RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED INCIDENT COULD NOT BE DETERMINED. JOHNSON & JOHNSON SURGICAL VISION WILL CONTINUE TO MONITOR THIS TYPE OF COMPLAINTS PER GLOBAL COMPLAINT TRENDING. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL NARRATIVE INFORMATION: TELEPHONE NUMBER: (B)(6). A REVIEW OF RECORDS RELATED TO THE DEVICE INCLUDING LABELING, COMPLAINT TRENDING, AND RISK DOCUMENTATION WILL BE PERFORMED. UPON COMPLETION OF THIS REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: AT THE TIME OF INITIAL FILING FOLLOWING HEALTH EFFECT IMPACT CODE AND CLINICAL CODE WAS INADVERTENTLY MISSED, HENCE THIS IS BEING ADDED. SECTION H6: HEALTH EFFECT-IMPACT CODE ¿ 4625 FOR SECONDARY SURGICAL INTERVENTION: SURGICAL INTERVENTION SECTION H6: HEALTH EFFECT-CLINICAL CODE ¿ 1789 FOR STRIAE IN DESCEMET'S : CORNEAL STRIAE. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CUSTOMER FOUND NUCLEAR FRAGMENTS REMAINED IN THE ANTERIOR CHAMBER DURING THE POST EXAMS. SURGEON PERCEIVED THAT THE VACUUM PERFORMANCE DURING IRRIGATION ASPIRATION AND PHACO MODE WAS BIT LOW. THE ISSUE HAD OCCURRED IN THREE PROCEDURES SINCE AFTER THE MACHINE WAS CHECKED ON (B)(6) 2023. REPORTEDLY TRANSCONJUNCTIVAL SINGLE PLANE SCLERCORNEAL INCISION METHOD WAS USED WITH 2.55 MM INCISION SIZE. THERE WAS NO INCISION WIDENED. IRRIGATION, SUCTION, AND REMOVAL WITH IRRIGATION ASPIRATION IS PLANNED FOR END OF MARCH 2023. PATIENT WAS PRESCRIBED WITH MEDICATION (LEVOFLOXACIN, SANBETASON). THE PATIENT OUTCOME WAS REPORTED AS GOOD VISUAL ACUITY WITH NO PROBLEMS. THE PACK WAS REUSED FOR THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED, AND IT WAS LEARNT THAT ON (B)(6) 2023 THERE WAS REMOVAL OF RESIDUAL NUCLEAR FRAGMENTS PERFORMED USING OPHTHALMIC ANESTHESIA. SURGEON ASPIRATED BY USING A BI-MANUAL IRRIGATION ASPIRATION (IA) WHILE SHATTERING NUCLEAR FRAGMENTS WITH THE TIP. NUCLEAR FRAGMENTS WERE ASPIRATED WITHOUT PROBLEMS. THERE WAS DESCEMET'S FOLD THAT SEEMED TO BE CAUSED BY AN EFFECT OF THE BI-MANUAL IA OPERATION. AS A RESULT, VISUAL ACUITY DECREASED FROM 0.9 TO 0.6, BUT ACCORDING TO THE DOCTOR, IT IS LIKELY TO RECOVER GRADUALLY. THIS EVENT WILL CAPTURE INFORMATION FOR 1 OF 3 PATIENTS. OTHER REPORTS ARE BEING SUBMITTED FOR OTHER PATIENTS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2020425 ELLIPS FX PHACO HANDPIECE UNIT, PHACOFRAGMENTATION HQC AMO MANUFACTURING USA, LLC 690880 E246684 05050474537132

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention