BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRALASE

    MDR report key: 7426522 · Received April 12, 2018

    Report

    Report Number
    3006695864-2018-00773
    Event Type
    Malfunction
    Date Received
    April 12, 2018
    Date of Event
    March 14, 2018
    Report Date
    May 17, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE AVAILABLE FOR EVALUATION? YES. RETURNED TO MANUFACTURER ON: 03/22/2018. DEVICE RETURNED TO MANUFACTURER? YES. DEVICE EVALUATION: PATIENT INTERFACE LOT# 60097288 WAS RECEIVED AT (B)(6) INVESTIGATION LAB FOR FURTHER INVESTIGATION. A VISUAL ASSESSMENT OF THE RETURNED SAMPLE AND FOUND NO DAMAGES ON THE DEVICE. SUCTION TEST WAS PERFORMED. THE RETURNED SAMPLE PERFORMED AS INTENDED. THE REPORTED EVENT OF SUCTION LOSS COULD NOT 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 PATIENT INTERFACE LOT# 60097288. 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. IF THERE IS ANY FURTHER RELEVANT INFORMATION, A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND 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). PER ACCOUNT, SUCTION LOSS OCCURRED TWICE ON RIGHT EYE (OD) WITH FEMALE PATIENT. FIRST SUCTION LOSS EVENT OCCURRED PRIOR TREATMENT, WHILE THE OTHER SUCTION LOSS EVENT OCCURRED DURING THE RASTER PATTERN. SURGERY WAS COMPLETED SUCCESSFULLY WITH NEW SUCTION RING ON THE THIRD ATTEMPT. SUCTION LOSS WAS DUE TO SUCTION RING ISSUE PER PHYSICIAN. THE PHYSICIAN FURTHER STATED THAT THE PATIENT WAS NOT MOVING OR SQUEEZING THE EYE. THE PATIENT DID NOT EXPERIENCE LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA) AND TREATMENT WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269841 INTRALASE PATIENT INTERFACE HNO JOHNSON & JOHNSON SURGICAL VISION, INC. PI-RET 60097288 15050474534688

    Patients

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