BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE

    MDR report key: 8864070 · Received August 6, 2019

    Report

    Report Number
    3006695864-2019-00632
    Event Type
    Injury
    Date Received
    August 6, 2019
    Date of Event
    July 13, 2019
    Report Date
    November 11, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CORRECTION MDR IS BEING SUBMITTED TO ADDRESS INACCURATE INFORMATION IN SECTION F ON THE XML VERSION OF THE PREVIOUS SUBMISSION CAUSED BY A SOFTWARE GLITCH IN THE TRANSMISSION PROCESS. THE INTERNAL NON-CONFORMANCE NUMBERS FOR THIS SOFTWARE ISSUE ARE (B)(4) AND CAPA-010215.

    Additional Manufacturer Narrative · 1

    LOT NUMBER IS UNKNOWN AS IT WAS NOT PROVIDED. EXPIRATION DATE IS UNKNOWN AS THE LOT NUMBER WAS NOT PROVIDED. UNIQUE IDENTIFIER IS UNKNOWN AS LOT NUMBER WAS NOT PROVIDED. MANUFACTURING DATE IS UNKNOWN. (B)(4). 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

    THE SURGERY CENTER REPORTED SUCTION LOSS WHILE LASER FIRING DURING RASTER PATTERN. THE TREATMENT WAS ABORTED. PATIENT TREATMENT TO BE COMPLETED AT A LATER DATE. PRE-OP BCVA FROM (B)(6) 2019: RIGHT EYE: 20/20 -2.00 X -.50 X 10, LEFT EYE: 20/20 -1.75 X -.50 X 6.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660799 INTRALASE PATIENT INTERFACE HNO JOHNSON & JOHNSON SURGICAL VISION, INC. PI-RET UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention FEMTOSECOND LASER (B)(6)| FEMTOSECOND LASER (B)(4)