BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK_PHACO TIP/NEEDLE

    MDR report key: 20280742 · Received September 23, 2024

    Report

    Report Number
    3012236936-2024-000260
    Event Type
    Malfunction
    Date Received
    September 23, 2024
    Date of Event
    August 1, 2024
    Report Date
    December 13, 2024
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT RETURNED TO THE MANUFACTURING SITE FOR EVALUATION. ADDITIONAL INFORMATION: SECTION D9: DEVICE AVAILABLE FOR EVALUATION? NO SECTION D10 CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES DETAIL OF PRODUCT AND DATE MEDICAL PRODUCT OM055002 SECTION H3: EVALUATED BY MANUFACTURER: NO. PRODUCT INVESTIGATION: THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION. NEITHER DEVICE PART NUMBER NOR LOT NUMBER WAS PROVIDED, THEREFORE BHR REVIEW CANNOT BE PERFORMED. DFU (Z311242) OF HANDLE OM055002 LISTS MULTIPLE I/A TIPS (PART NUMBER STARTS WITH OM055101) WHICH CAN BE USED ON OM055002 HANDLE. THE RECORD SHOWS THAT A TOTAL OF (B)(4) I/A TIPS (PART NUMBER STARTS WITH OM055101) WERE SHIPPED TO JOHNSON AND JOHNSON IN THE PAST YEAR AND THIS IS THE SEVENTH COMPLAINT BEING REPORTED. ALL 7 COMPLAINTS WERE ABOUT DIFFERENT ISSUES. THIS COMPLAINT IS FILED AS "UNABLE TO DETERMINE" SINCE THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION SO THE REPORTED ISSUE CANNOT BE CONFIRMED. THE REPORTED ISSUE IS MONITORED BY MONTHLY COMPLAINT METRICS AT AN ACCEPTABLE RATE, AND THE RISK ASSOCIATED WITH THE ISSUE IS CONSIDERED LOW, SO NO ACTION IS REQUIRED AT THIS TIME. ACTION WILL BE TAKEN TO ADDRESS THE ISSUE WHEN IT BECOMES NECESSARY. INVESTIGATION WAS PERFORMED BY MICROSURGICAL TECHNOLOGY, INC. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION A4, A5 AND A6: UNKNOWN/ NOT PROVIDED. SECTION D4: MODEL NUMBER: UNKNOWN, INFORMATION NOT PROVIDED. SECTION D4: CATALOG NUMBER: A COMPLETE CATALOG # IS UNKNOWN, SECTION D4: LOT NUMBER: UNKNOWN, INFORMATION NOT PROVIDED. SECTION D4: UDI NUMBER: A COMPLETE UDI NUMBER IS UNKNOWN. SECTION D6A: IMPLANT DATE: NOT APPLICABLE AS THIS IS NOT AN IMPLANTABLE DEVICE. SECTION D6B: EXPLANT DATE: NOT APPLICABLE AS THIS IS NOT AN IMPLANTABLE DEVICE. SECTION E1: EMAIL ADDRESS: UNKNOWN/NOT PROVIDED. SECTION E1: TELEPHONE NUMBER: (B)(6). SECTION H3: OTHER 81: 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. AN ATTEMPT HAS BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE MEDICAL STAFF ROUTINELY USED THE IA INJECTION AND SUCTION HANDLE TO CLEAN THE CORTEX AND POLISH OF THE LENS IN THE PERIPHERY OF THE EYE DURING THE CATARACT SURGERY FOR THE PATIENT. DURING THE SURGERY, THE NEEDLE BROKE. THERE WERE CONCERNS IT COULD CAUSE INTRAOCULAR FOREIGN BODY, NEEDLE MAY BE DIFFICULT TO REMOVE, OR NEEDLE COULD FALL INTO THE VITREOUS CAVITY WHICH MAY REQUIRE TRANSFER FOR REMOVAL WHICH COULD CAUSE RETINAL DAMAGE. THE HANDLE WAS REPLACED. THERE WAS NO DELAY IN TREATMENT OR OTHER INTERVENTIONS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1488831 UNK_PHACO TIP/NEEDLE PHACO TIP HQC JOHNSON & JOHNSON SURGICAL VISION, INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female OM055002| SN (B)(6)