BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHACO ACCESSORIES

    MDR report key: 7738388 · Received August 1, 2018

    Report

    Report Number
    3006695864-2018-01595
    Event Type
    Malfunction
    Date Received
    August 1, 2018
    Date of Event
    July 9, 2018
    Report Date
    November 2, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC
    Product Code
    HQC
    PMA / PMN Number
    K060366
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: ADDITIONAL INFORMATION WAS PROVIDED THAT INDICATED THE DEVICE REPORTED WAS NOT A JOHNSON & JOHNSON DEVICE. UPON REVIEWING THE COMPLAINT FOLDER, IT HAS BEEN DETERMINED THIS REPORT IS NO LONGER A REPORTABLE EVENT. THEREFORE, AN EMDR IS REQUIRED TO STATE THAT NO FURTHER FOLLOW UPS WILL BE SENT OUT. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    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 NR-0148919 AND CAPA-010215.

    Additional Manufacturer Narrative · 1

    BRAND NAME IS UNKNOWN AS IT WAS NOT PROVIDED. MODEL NO. IS UNKNOWN AS IT WAS NOT PROVIDED. LOT NO. IS UNKNOWN AS IT WAS NOT PROVIDED. UNIQUE IDENTIFIER (UDI#) IS UNKNOWN AS LOT NO. WAS NOT PROVIDED. MANUFACTURER DATE IS UNKNOWN AS LOT NO WAS NOT PROVIDED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A CLOG DURING A CATARACT PROCEDURE USING A 19-GAUGE TIP NEEDLE. A JOHNSON & JOHNSON PHACO SPECIALIST WAS AT THE SITE LOCATION WHEN THE PROBLEM OCCURRED. THE PHACO SPECIALIST CHECKED THE SURGEON¿S SETTINGS AND FOUND THE VACUUM SETTINGS WERE PROGRAMMED VERY HIGH WITH A PUMP RAMP SPEED OF 65. THE VACUUM AND RAMP WERE TURNED DOWN TO LOWER SETTINGS SO THAT THE NUCLEUS HAS TIME TO EMULSIFY WITH A LOWER SURGEON PROGRAM. THE SPECIALIST BELIEVED THE SURGEON IS CONSUMING THE MATERIAL TOO QUICKLY CAUSING A CLOG IN THE TUBING AND AT TIMES THE HANDPIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583016 PHACO ACCESSORIES HQC JOHNSON & JOHNSON SURGICAL VISION, INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 TUBING OPO73, LOT NO. 60119974.| TUBING OPO73, LOT NO. 60119974