BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FS DISPOSABLE INTERFACE

    MDR report key: 12081864 · Received June 29, 2021

    Report

    Report Number
    3006695864-2021-08000
    Event Type
    Malfunction
    Date Received
    June 29, 2021
    Report Date
    August 23, 2021
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    GEX
    UDI-DI
    15050474534688
    PMA / PMN Number
    K060372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    D9. RETURNED TO MANUFACTURER ON: JULY 1, 2021 H3. DEVICE EVALUATED BY MANUFACTURER? YES H6: INVESTIGATION CODES: 10, 3331, 4109, 4110 H6: INVESTIGATION FINDINGS: 213 1 OPENED PI WAS RECEIVED AT SANTA ANA INVESTIGATION LAB FOR FURTHER EVALUATION. VISUAL INSPECTION WAS PERFORMED, AND NO OBVIOUS DAMAGE/DEFECT WAS OBSERVED. SUCTION TEST WAS PERFORMED, AND ALL RESULTS WERE FOUND WITHIN SPECIFICATIONS. THE REPORTED EVENT CANNOT BE CONFIRMED. MANUFACTURING RECORD REVIEW: PER MANUFACTURING RECORDS REVIEW REPORT ALL DEVICES MEET MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS AT THE TIME OF PRODUCT RELEASE. 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

    EXACT DATE NOT KNOW HOWEVER, THE ACCOUNT SAID THE SURGERY DATE WAS BETWEEN (B)(6) 2021 AND (B)(6) 2021. 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. A MANUFACTURER RECORD REVIEW RELATED TO THE DEVICE INCLUDING DEVICE HISTORY RECORD WILL BE PERFORMED. UPON COMPLETION OF THIS REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED THAT CHANGES THE FACTS AND/OR CONCLUSION, 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

    IT WAS REPORTED THAT DURING A FLAP PROCEDURE AND WHILE LASER WAS FIRING THE PATIENT INTERFACE EXPERIENCED A SUCTION LOSS. IT WAS REPORTED THAT PROCEDURE WAS COMPLETED SUCCESSFULLY AND PATIENT DID NOT REQUIRE SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    979135 FS DISPOSABLE INTERFACE POWERED LASER SURGICAL INSTRUMENT GEX AMO MANUFACTURING USA, LLC 590106AN 60279925 15050474534688

    Patients

    Seq Age Sex Outcome Treatment
    1 INTRALASE LASER SN UNKNOWN.| INTRALASE LASER SN UNKNOWN