BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    FS DISPOSABLE INTERFACE

    MDR report key: 19857465 · Received July 29, 2024

    Report

    Report Number
    3012236936-2024-000210
    Event Type
    Malfunction
    Date Received
    July 29, 2024
    Report Date
    April 29, 2025
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H10 -LIST OF ALL LOT NUMBERS OF THE DEVICES AND QUANTITY 60262695 (X3). 60336894 (X1). 60403114 (X20). 60403116 (X2). 60425406 (X2). 60429450 (X2). 60432228 (X2). 60435937 (X1). 60438010 (X3). 60438011 (X1).. 60452938 (X5). 60465454 (X2). 60466809 (X9). 60466811 (X6). 60468464 (X1). 60468466 (X10). 60471936 (X1). 60473970 (X1). 60475838 X5). 60475839 (X1). 60475840 (X2). 60477945 (X2). 60477946 (X3). 60479309 (X3). 60479311 (X1). 60483039 (X11). 60485637 (X2). 60485638 (X2). 60487821 (X3). 60489877 (X5). 60489878 (X4). 60491594 (X6). 60491596 (X2). 60491597(X5). 60493224 (X7). 60493225 (X4). 60499858 (X1). 60499859 (X7). 60499860 (X10). 60504465 (X2). 60504466 (X3). 60506730 (X5). 60508895 (X4). 60511019 (X2). 60511020 (X10). UNKNOWN (X9). FORTY FIVE (45) INVESTIGATIONS WERE COMPLETED DURING THE PERIOD. A REVIEW OF THE RECORDS RELATED TO THE DEVICE THAT INCLUDED LABELING, MANUALS, TRENDING, RISK DOCUMENTATION AND DEVICE HISTORY RECORD (DHR) SHOWED THAT THE SYSTEM AND ITS COMPONENTS MET ALL SPECIFICATIONS PRIOR TO BEING RELEASED. NO PRODUCT DEFICIENCY WAS IDENTIFIED. THE PATIENT INTERFACE (PI) SUCTION RING MAY LOSE SUCTION DURING A PROCEDURE. LABEL COPY STATES CORNEAL FIXATION VACUUM LOSS CAN OCCUR. THERE ARE SEVERAL FACTORS THAT MAY CONTRIBUTE TO SUCTION ISSUES SUCH AS DOCTOR¿S TECHNIQUE IN APPLYING THE SUCTION RING TO THE CORNEA, DOCTOR¿S TECHNIQUE IN SQUEEZING THE PI CLIP TO SECURE THE SUCTION RING TO THE PI CONE AND PATIENT ANATOMY AFFECTING THE INTERFACE BETWEEN THE PATIENT¿S CORNEA AND THE SUCTION RING. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: FOUR (4) INVESTIGATIONS HAVE BEEN COMPLETED DURING THE PERIOD. FROM THOSE THREE (3) WERE UNABLE TO BE COMPLETED AS THE RETURN PRODUCT WAS RECEIVED LOOSE WITHIN A BIOHAZARD BAG AND INDIVIDUAL PRODUCT COMPONENTS COULD NOT BE ASSOCIATED WITH THEIR CORRESPONDING LOT NUMBERS. THE OTHER PRODUCT THAT WAS RETURNED WAS INCOMPLETE AND TESTING COULD NOT BE DONE. A REVIEW OF THE RECORDS RELATED TO THE DEVICE THAT INCLUDED LABELING, TRENDING, AND RISK DOCUMENTATION REVIEWS WAS PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWED THAT THE SYSTEM AND ITS COMPONENTS MET ALL SPECIFICATIONS PRIOR TO BEING RELEASED. THE RISKS AND MITIGATIONS ASSOCIATED WITH THE COMPLAINT ISSUE ARE IDENTIFIED IN EXISTING RISK DOCUMENTS AND NO NEW RISKS WERE IDENTIFIED AS PART OF THIS INVESTIGATION.

    Additional Manufacturer Narrative · 0

    MANUFACTURER NARRATIVE - DEVICE EVALUATION: TWO (2) INVESTIGATIONS WERE COMPLETED DURING THE PERIOD. A REVIEW OF THE RECORDS RELATED TO THE DEVICE THAT INCLUDED LABELING, MANUALS, TRENDING, AND DEVICE HISTORY RECORD (DHR) SHOWED THAT THE SYSTEM AND ITS COMPONENTS MET ALL SPECIFICATIONS PRIOR TO BEING RELEASED. THE TWO (2) RETURNED DEVICES DID NOT PASS THE SUCTION TEST. AS IT CANNOT BE DETERMINED THAT THE ISSUE IS TRACED TO THE DESIGN, MANUFACTURING, OR LABELING, PRODUCT DEFICIENCY CANNOT BE CONFIRMED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: FORTY NINE (49) INVESTIGATIONS WERE COMPLETED DURING THE PERIOD. FOR ONE OF THE DEVICES THE PRODUCT WAS RECEIVED BROKEN AND FUNCTIONAL TESTING WAS UNABLE TO BE DONE. FOR THE REST OF THE DEVICES NO ISSUES WERE FOUND. A REVIEW OF THE RECORDS RELATED TO THE DEVICES THAT INCLUDED LABELING, MANUALS, TRENDING, AND RISK DOCUMENTATION REVIEWS WAS PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) SHOWED THAT THE DEVICES AND ITS COMPONENTS MET ALL SPECIFICATIONS PRIOR TO BEING RELEASED. THE RISKS AND MITIGATIONS ASSOCIATED WITH THE COMPLAINT ISSUE ARE IDENTIFIED IN EXISTING RISK DOCUMENTS AND NO NEW RISKS WERE IDENTIFIED AS PART OF THIS INVESTIGATION. NO PRODUCT DEFICIENCY WAS IDENTIFIED. THE PATIENT INTERFACE (PI) SUCTION RING MAY LOSE SUCTION DURING A PROCEDURE. LABEL COPY STATES CORNEAL FIXATION VACUUM LOSS CAN OCCUR. THERE ARE SEVERAL FACTORS THAT MAY CONTRIBUTE TO SUCTION ISSUES SUCH AS DOCTOR¿S TECHNIQUE IN APPLYING THE SUCTION RING TO THE CORNEA, DOCTOR¿S TECHNIQUE IN SQUEEZING THE PI CLIP TO SECURE THE SUCTION RING TO THE PI CONE AND PATIENT ANATOMY AFFECTING THE INTERFACE BETWEEN THE PATIENT¿S CORNEA AND THE SUCTION RING. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES 156 MALFUNCTION EVENTS. THE EVENT WAS RELATED TO SUCITON LOSS WHILE LASER FIRING. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281825 FS DISPOSABLE INTERFACE POWERED LASER SURGICAL INSTRUMENT HNO JOHNSON & JOHNSON SURGICAL VISION, INC. 590106AN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown