BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IRRIGATION/ASPIRATION TIP

    MDR report key: 11716035 · Received April 23, 2021

    Report

    Report Number
    2020664-2021-07028
    Event Type
    Malfunction
    Date Received
    April 23, 2021
    Date of Event
    March 30, 2021
    Report Date
    April 23, 2021
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQC
    PMA / PMN Number
    K121721
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER IS UNKNOWN AS IT WAS NOT PROVIDED. LOT NUMBER IS UNKNOWN AS IT WAS NOT PROVIDED. A COMPLETE UNIQUE IDENTIFIER (UDI) NUMBER UNKNOWN AS PRODUCT LOT NUMBER WAS NOT PROVIDED. TELEPHONE: (B)(6). MANUFACTURER DATE IS UNKNOWN AS LOT NUMBER WAS NOT PROVIDED. DEVICE EVALUATION: PRODUCT WAS NOT AVAILABLE FOR FURTHER EVALUATION. THEREFORE, NO TESTING COULD BE PERFORMED. THE REPORTED EVENT CANNOT BE CONFIRMED. MANUFACTURING RECORDS REVIEW: THE LOT NUMBER WAS NOT REPORTED AND CANNOT BE OBTAINED. THEREFORE, COMPLAINT HISTORY REVIEW CANNOT BE PERFORMED. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    DURING A CATARACT PROCEDURE, THE SURGERY CENTER REPORTED A LOOSE TIP DURING PROCEDURE. A DESCRIPTION FROM THE SURGERY CENTER INDICATED WHILE ASPIRATING A HARD NUCLEUS, THE ASPIRATION BECAME WEAK. TO RESOLVE THE ASPIRATION ISSUE, THE TUBING CASSETTE AND HANDPIECE WERE REPLACED. AFTER THE REPLACEMENT OF THE ACCESSORIES, A 501-PRIME EXCESSIVE VACUUM AND A 285-LOOSE TIP ERROR OCCURRED DURING THE CATARACT PROCEDURE. AT THE ADVICE OF TECHNICAL SUPPORT, THE PHACO TIP WAS REPLACED. THE TIP REPLACEMENT RESOLVED THE ISSUE. THE PROCEDURE WAS COMPLETED. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609439 IRRIGATION/ASPIRATION TIP UNIT, PHACOFRAGMENTATION HQC JOHNSON & JOHNSON SURGICAL VISION, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1