BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_PHACO TIP/NEEDLE

    MDR report key: 18244022 · Received December 1, 2023

    Report

    Report Number
    3012236936-2023-02895
    Event Type
    Injury
    Date Received
    December 1, 2023
    Date of Event
    October 6, 2023
    Report Date
    December 27, 2024
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC
    Product Code
    HQC
    UDI-DI
    05050474537132
    PMA / PMN Number
    K121721
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2, A4 AND A5: PER REGULATION EU (B)(4) (GENERAL DATA PROTECTION REGULATION), PATIENT IDENTIFIERS WERE NOT COLLECTED OR RECORDED AND THEREFORE ARE NOT AVAILABLE. SECTION D4 - EXPIRATION DATE: DOES NOT APPLY. SECTION D6A - IMPLANT DATE: NOT APPLICABLE. PHACO HANDPIECE IS NOT AN IMPLANTABLE DEVICE. SECTION D6B - EXPLANT DATE: NOT APPLICABLE. PHACO HANDPIECE IS NOT AN IMPLANTABLE DEVICE; THEREFORE, NOT EXPLANTED. SECTION E1 - TELEPHONE NUMBER: (B)(6). SECTION H6 -HEALTH EFFECT - CLINICAL CODE: 4471: ENLARGEMENT OF INCISION . SECTION H3 - OTHER (81): THE MATERIAL WAS NOT RETURNED FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT 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 AND POSSIBLE PRODUCT RETURN AND EVALUATION, 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.

    Additional Manufacturer Narrative · 0

    CORRECTION: AFTER FURTHER REVIEW OF THE FILE IT WAS DETERMINED THAT THE SUSPECT PRODUCT SHOULD BE THE PHACO TIP AND NOT THE ELLIPS PHACO HANDPIECE. SECTION D1 BRAND NAME: UNK_PHACO TIP/NEEDLE SECTION D2A COMMON DEVICE NAME: PHACO ACCESSORY SECTION D2B DEVICE PRODUCT CODE: HQC SECTION D3 ESTABLISHMENT NAME: JOHNSON & JOHNSON SURGICAL VISION, INC. 31 SECTION D3 COUNTRY: UNITED STATES OF AMERICA SECTION D3 ADDRESS: 31 TECHNOLOGY DRIVE SECTION D3 CITY: IRVINE SECTION D3 STATE: CALIFORNIA SECTION D3 ZIP CODE: 92618 SECTION D4 MODEL NUMBER: UNKNOWN AS LOT NUMBER WAS NOT PROVIDED SECTION D4 CATALOG NUMBER: UNKNOWN AS LOT NUMBER WAS NOT PROVIDED SECTION D4 LOT NUMBER: UNKNOWN AS LOT NUMBER WAS NOT PROVIDED SECTION D4 PRIMARY UNIQUE DEVICE IDENTIFICATION (UDI) NUMBER: A COMPLETE UDI # IS UNKNOWN AS PRODUCT LOT NUMBER WAS NOT PROVIDED. A PARTIAL NUMBER HAS BEEN PROVIDED SECTION G4 PMA/510(K) NUMBER: K121721. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING INVESTIGATION IS FOR THE PHACO TIP/NEEDLE: DEVICE EVALUATION: THE PRODUCT TESTING COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. THE REPORTED COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORD REVIEW: MANUFACTURING RECORD REVIEW CANNOT BE PERFORMED SINCE THE LOT NUMBER IS UNKNOWN AND CANNOT BE OBTAINED. A COMPLAINT HISTORICAL REVIEW OF THE MANUFACTURING PRODUCTION ORDER NUMBER CANNOT BE PERFORMED SINCE THE LOT NUMBER IS UNKNOWN. CONCLUSION: NO SAMPLE WAS RETURNED, AND THE LOT NUMBER IS UNKNOWN, AN INVESTIGATION COULD NOT BE PERFORMED, AND NO MALFUNCTION IS CONFIRMED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE CATARACT OPERATION, THE SURGEON INITIATED PHACOEMULSIFICATION AND THE TIP OF THE HANDPIECE ABNORMALLY HEATED AND CAUSED A CORNEAL BURN AND AN ABNORMAL ENLARGEMENT OF THE INCISION. THIS OCCURRED DURING THE FIRST GROOVE PHASE. THE PHACO TEST FUNCTIONED NORMALLY, AND THE HANDPIECE WAS INITIALLY AT A COOL TEMPERATURE. THE SURGERY WAS STOPPED TO REPLACE THE TIP AND HANDPIECE. THE PATIENT'S CURRENT CONDITION INCLUDES TWO SUTURES PLACED FOLLOWING THE INCISION BURN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1592745 UNK_PHACO TIP/NEEDLE PHACO ACCESSORY HQC JOHNSON & JOHNSON SURGICAL VISION, INC UNKNOWN UNKNOWN 05050474537132

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention