BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELLIPS FX PHACO HANDPIECE

    MDR report key: 20828236 · Received December 2, 2024

    Report

    Report Number
    3012236936-2024-000322
    Event Type
    Injury
    Date Received
    December 2, 2024
    Date of Event
    November 4, 2024
    Report Date
    February 10, 2025
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQC
    UDI-DI
    05050474537132
    PMA / PMN Number
    K981116
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H3 DEVICE EVALUATED BY MANUFACTURER: YES. SECTION H4 DEVICE MANUFACTURE DATE: JUN 8, 2016. DEVICE EVALUATION: THE PRODUCT WAS EVALUATED BY TECHNICIAN DURING FIELD SERVICE. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE DEVICE WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION A4: 145 POUNDS SECTION A5: NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER ASIAN, NOT HISPANIC/NOT LATINO SECTION B3 DATE OF EVENT: NOV 4, 2024 SECTION D4 SERIAL NUMBER: (B)(6). SECTION D4 UDI#: (B)(4). CUSTOMER REPORTED THAT THE HANDPIECE IS NOT BEING RETURNED FOR INVESTIGATION. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION A4 AND A5: UNKNOWN/ NOT PROVIDED. D10 - CONCOMITANT - WHITESTAR SN (B)(6), PHACO TIP UNKNOWN LOT NUMBER. SECTION H3: THE DEVICE WAS NOT RETURNED FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYSTEM PRIMED AND TUNED CORRECTLY PRIOR TO THE CASE BUT DURING PHACO, THE MACHINE WAS GIVING THE OCCLUSION SOUND (DINGING) ALTHOUGH THE MACHINE WAS NOT OCCLUDED. AT THAT POINT, THE DOCTOR APPLIED MORE PHACO POWER THAN NEEDED. HE THOUGHT THERE MUST HAVE BEEN SOME LENS MATERIAL OCCLUDING THE TIP (THAT WAS THE SIGNAL FOR HIM TO DEPRESS THE FOOT PEDAL TO APPLY POWER). AS A RESULT OF THIS, A WOUND BURN OCCURRED ON THE PATIENT'S RIGHT EYE. DOCTOR TRIED FLUSHING THE HANDPIECE WITH SALINE, ASSUMING IT WAS OCCLUDED SOMEWHERE, BUT IT FLUSHED NORMALLY. AFTER THIS, THE DOCTOR TRIED USING THE HANDPIECE AGAIN AND HAD THE SAME ISSUE. THEY RERAN THE PRIME AND TUNE WHICH GAVE AN ERROR FOR "LOOSE HANDPIECE." THEY THEN GOT ANOTHER HANDPIECE WHICH PRIMED AND TUNED CORRECTLY AND FINISHED THE PHACO PORTION OF THE PROCEDURE NORMALLY. DOCTOR COULD NOT GET THE MAIN INCISION TO SEAL WITH AGGRESSIVE HYDRATION (DUE TO THE WOUND BURN), SO ULTIMATELY PLACED A SUTURE. THE PATIENT HAS DONE VERY WELL. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. THIS REPORT IS AGAINST THE HANDPIECE. A SEPARATE REPORT WILL BE FILED AGAINST THE TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2290092 ELLIPS FX PHACO HANDPIECE UNIT, PHACOFRAGMENTATION HQC JOHNSON & JOHNSON SURGICAL VISION, INC. 690880 05050474537132

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Required Intervention