BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRALASE

    MDR report key: 7395230 · Received April 4, 2018

    Report

    Report Number
    3006695864-2018-00682
    Event Type
    Malfunction
    Date Received
    April 4, 2018
    Date of Event
    February 9, 2018
    Report Date
    May 22, 2018
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HNO
    UDI-DI
    15050474534688
    PMA / PMN Number
    K060372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE AVAILABLE FOR EVALUATION? YES. RETURNED TO MANUFACTURER ON: 3/29/2018. DEVICE RETURNED TO MANUFACTURER? YES. DEVICE EVALUATION: TWO (2) PATIENT INTERFACE (PI) LOT# 60097286 WERE RECEIVED AT SANTA ANA INVESTIGATION LAB FOR FURTHER INVESTIGATION. A VISUAL ASSESSMENT OF THE RETURNED PIS FOUND NO DAMAGES. SUCTION TEST WAS PERFORMED ON THE TWO (2) RETURNED PIS. THE TWO (2) PIS WERE FOUND TO FUNCTION AS INTENDED. THE REPORTED EVENT OF SUCTION LOSS CANNOT BE REPLICATED OR CONFIRMED. MANUFACTURING RECORD REVIEW: PER MANUFACTURING RECORDS REVIEW REPORT PROVIDED BY THIRD-PARTY MANUFACTURER, NO RELATED NON-CONFORMITY OR DEVIATIONS WERE ISSUED DURING MANUFACTURING THE PI LOT 60097286. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WAS REVIEWED. THE DFU ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS FOR THE PROPER USE AND HANDLING OF THE PRODUCT. CONCLUSION: BASED ON THE INVESTIGATION RESULTS THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    THE SURGERY CENTER REPORTED SUCTION LOSS DURING SURGERY. THE SUCTION RING ASSEMBLY ISSUE WITH AN INTRALASE PATIENT INTERFACE (PI) OCCURRED AFTER THE PATIENT WAS APPLANATED AND AFTER THE LASER FIRED. IT WAS NOTED THAT THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INJURY REPORTED AND NO SURGICAL INTERVENTION WAS REQUIRED. THIS REPORT IS TWO(2) OF TWO (2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239019 INTRALASE PATIENT INTERFACE HNO JOHNSON & JOHNSON SURGICAL VISION, INC. PI-RET 60097286 15050474534688

    Patients

    Seq Age Sex Outcome Treatment
    1 FEMTO LASER, SN (B)(4)