BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRALASE

    MDR report key: 7652947 · Received June 29, 2018

    Report

    Report Number
    3006695864-2018-01438
    Event Type
    Malfunction
    Date Received
    June 29, 2018
    Date of Event
    May 16, 2018
    Report Date
    August 10, 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
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE AVAILABLE FOR EVALUATION? YES. RETURNED TO MANUFACTURER ON: 06/27/2018. DEVICE RETURNED TO MANUFACTURER? YES. DEVICE EVALUATION: ONE (1) PATIENT INTERFACE (PI) WAS RECEIVED AT SANTA ANA INVESTIGATION LAB FOR FURTHER INVESTIGATION. RETURNED PI WAS RETURNED IN ORIGINAL PACKAGING CONFIRMING LOT# 60109500. A VISUAL INSPECTION OF THE DEVICE REVEALED NO OBVIOUS DAMAGE TO THE COMPONENTS AND ALL PARTS WERE ASSEMBLED CORRECTLY. SUCTION TESTING WAS PERFORMED AND THE RESULTS WERE OUTSIDE OF SPECIFICATION. THE REPORTED SUCTION ISSUE IS CONFIRMED. MANUFACTURING RECORD REVIEW: PER MANUFACTURING RECORDS REVIEW REPORT, NO RELATED NON-CONFORMITY OR DEVIATIONS WERE ISSUED DURING MANUFACTURING THE PI LOT# 60109500. ALL DEVICES MET MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS AT THE TIME OF PRODUCT RELEASED. CONCLUSION: BASED ON THE INVESTIGATION RESULTS, SUCTION ISSUE WAS CONFIRMED, BUT THERE WAS NO INDICATION OF ANY DESIGN OR MANUFACTURING ISSUE. HENCE, NON-CONFORMANCE REPORT WAS OPENED TO ADDRESS PI ISSUE AND JOHNSON & JOHNSON SURGICAL VISION WILL CONTINUE TO MONITOR THIS TYPE OF COMPLAINTS. 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. IF THERE IS ANY FURTHER RELEVANT INFORMATION, A SUPPLEMENTAL MEDWATCH WILL BE FILED. 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 WITH AN INTRALASE PATIENT INTERFACE (PI) AFTER THE PATIENT WAS APPLANATED AND AFTER LASER FIRED. IT WAS NOTED THAT ONE (1) IFLAP PROCEDURE WAS REPLACED AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INJURY REPORTED AND NO SURGICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493678 INTRALASE PATIENT INTERFACE HNO JOHNSON & JOHNSON SURGICAL VISION, INC. PI-RET 60109500 15050474534688

    Patients

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