BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAMINAR

    MDR report key: 19009616 · Received March 31, 2024

    Report

    Report Number
    3012236936-2024-00797
    Event Type
    Malfunction
    Date Received
    March 31, 2024
    Report Date
    March 31, 2024
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQC
    UDI-DI
    05050474573376
    PMA / PMN Number
    K121721
    Removal / Correction Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL NARRATIVE: NOTE: THIS MDR REPORT IS BEING SUBMITTED AS PART OF A REMEDIAL ACTION TO PREVENT SERIOUS INJURY. SECTION B3: DATE OF EVENT: UNKNOWN/NOT PROVIDED. SECTION D6A: IF IMPLANTED, GIVE DATE: NOT APPLICABLE AS THIS IS NOT AN IMPLANTABLE DEVICE. SECTION D6B: IF EXPLANTED, GIVE DATE: NOT APPLICABLE AS THIS IS NOT AN IMPLANTABLE DEVICE. 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. SECTION H9: THE JJSV REFERENCE NUMBER IS (B)(4). THE NUMBER WAS OMITTED DUE TO THE COMPLAINT HANDLING SYSTEM CHARACTER LIMITATION. JOHNSON & JOHNSON SURGICAL VISION (JJSV) HAS INITIATED A FIELD ACTION RELATED TO SELECT LOTS OF LAMINAR® FLOW IRRIGATION SLEEVE AND TEST CHAMBER ¿ 21 GAUGE (PART NUMBER: OPOHF21L) DUE TO A MANUFACTURING ISSUE WHICH COULD LEAD TO SUBPAR PERFORMANCE DURING CATARACT SURGERY. WHILE NOT ALL THE IRRIGATION SLEEVES IN THE RECALLED LOTS ARE AFFECTED, THIS NONCONFORMANCE COULD LEAD TO INSUFFICIENT FLOW OF BALANCED SALINE SOLUTION (BSS), WHICH MAY RESULT IN AN UNSTABLE ANTERIOR CHAMBER. THIS DEFECT COULD RESULT IN A CAPSULE TEAR, IRIS TRAUMA, OR CORNEAL EDEMA, OR IN RARE INSTANCES A CORNEAL INCISION BURN. COMPLAINTS WILL CONTINUE TO BE MONITORED AND INVESTIGATED. INVESTIGATION IS ONGOING AND CORRECTIVE ACTION WILL BE IMPLEMENTED AS APPROPRIATE. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ACCOUNT RECEIVED A BOX OF OPOHF21L WITH ONLY 1 IRRIGATION HOLE. THERE IS NO PATIENT ADVERSE EVENT TO REPORT. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1566153 LAMINAR UNIT, PHACOFRAGMENTATION HQC JOHNSON & JOHNSON SURGICAL VISION, INC. OPOHF21L 60479361 05050474573376

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown