BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE 20GA VITRECTOMY CUTTER & IRRI

    MDR report key: 14794771 · Received June 23, 2022

    Report

    Report Number
    3012236936-2022-01674
    Event Type
    Injury
    Date Received
    June 23, 2022
    Report Date
    January 6, 2025
    Manufacturer
    MEDICAL INSTRUMENT DEVELOPMENT LABS INC (MIDLABS)
    Product Code
    MLZ
    UDI-DI
    05050474534094
    PMA / PMN Number
    K081681
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PER CUSTOMER, THIS INFORMATION IS CONFIDENTIAL DUE TO THE GENERAL DATA PROTECTION ACT. DATE OF EVENT - UNKNOWN/NOT PROVIDED. TELEPHONE NUMBER: (B)(6). ADDITIONAL INFORMATION: J&J REPRESENTATIVE SPOKE WITH THE ACCOUNT. THE ACCOUNT REPORTED THAT PATIENT HAD ZONULAR FRAGILITY (INTRINSIC CONDITION OF THE HIGH-MYOPIC PATIENT). THE J&J REPRESENTATIVE REPORTED THAT THIS HAD NOTHING TO DO WITH THE SURGEON'S SKILL OR INEFFICIENCY OF THE INTUITIVE EQUIPMENT AND THAT SUCH A CIRCUMSTANCE COULD NOT HAVE BEEN AVOIDED AND COULD HAVE OCCURRED USING ANY EQUIPMENT ON THE MARKET. 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

    ADDITIONAL INFORMATION: DEVICE EVALUATION: THE PRODUCT WAS NOT RETURNED THEREFORE THE FAILURE COULD NOT BE DUPLICATED. MANUFACTURING RECORDS REVIEW: DEVICE HISTORY RECORD WAS CONDUCTED AND THESE LOTS WERE MANUFACTURED AND RELEASED IN ACCORDANCE WITH ACCEPTANCE CRITERIA. NO ANOMALY OR DEVIATION WAS FOUND. CONCLUSION: FAILURE WAS NOT CONFIRMED AS NO PRODUCT WAS RETURNED. CORRECTED DATA: SECTION H6: AS PART OF AN INTERNAL REVIEW OF OUR MDRS IT WAS IDENTIFIED THAT THE CODE 1069 PROVIDED ON THE INITIAL REPORT NEEDS TO BE CORRECTED. THE CORRECT MEDICAL DEVICE PROBLEM CODE IS 1384. ALSO, CODE 4632 WAS NOT ADDED TO THE INITIAL REPORT. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION D9: DEVICE AVAILABLE FOR EVALUATION: YES, RETURNED TO MANUFACTURER ON 09/12/2024 SECTION H3: DEVICE EVALUATED BY MANUFACTURER: YES. DEVICE EVALUATION: RECEIVED SIX PROBES. FIVE PROBES WERE IN ITS SEALED, UNUSED POUCHES. HE SIXTH PROBE ARRIVED IN AN OPENED BAG. NO VISUAL DEFECTS OBSERVED. FAILURE DUPLICATION TESTS WERE PERFORMED, FUNCTIONAL TEST PASSED FOR THE FIRST FIVE PROBES (FROM THE SEALED, UNUSED POUCHES). THE SIXTH PROBE PASSED ALL FUNCTIONAL TESTING EXCEPT THE CUT TEST (SINGLE CUT AT 60 CPM). PROBES ARE BEYOND THE EXPIRATION DATE. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE DEVICE WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. CONCLUSION: FIVE OF SIX RETURNED PROBE SAMPLES PASSED ALL FUNCTIONAL TESTS. THE FINAL PROBE PASSED ALL FUNCTIONAL TESTS EXCEPT THE PROBE CUTTING PERFORMANCE TEST (SINGLE CUT AT 60 CPM). THE ROOT CAUSE OF THE FAILURE COULD NOT BE DETERMINED AS ALL THE RETURNED PROBE SAMPLES ARE BEYOND THE EXPIRATION DATE (2024-03-30), PER THE CUSTOMER PACKAGING. PRODUCT FUNCTIONALITY CANNOT BE GUARANTEED AFTER ITS EXPIRATION. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ANTERIOR VITRECTOMY WAS NECESSARY DUE TO RUPTURE OF THE POSTERIOR LENS CAPSULE DURING CATARACT SURGERY USING THE PHACOEMULSIFICATION TECHNIQUE. THIS WAS USING THE COMPACT INTUITIVE SYSTEM AND A VITRECTOMY PROBE WHICH DIDN'T WORK THEREFORE, PATIENT WAS TRANSFERRED TO ANOTHER CLINIC TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR THE VITRECTOMY CUTTER. REFER TO 3012236936-2022-01675 FOR THE REPORT OF THE COMPACT INTUITIVE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264426 DISPOSABLE 20GA VITRECTOMY CUTTER & IRRI VITRECTOMY, INSTRUMENT CUTTER MLZ MEDICAL INSTRUMENT DEVELOPMENT LABS INC (MIDLABS) NGP0020 60289909 05050474534094

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention COMPACT SN: (B)(6).