BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGNATURE PACK, DISPOSABLE TUBING

    MDR report key: 10928452 · Received December 1, 2020

    Report

    Report Number
    3006695864-2020-00518
    Event Type
    Injury
    Date Received
    December 1, 2020
    Report Date
    January 26, 2021
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQC
    PMA / PMN Number
    K060366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    B5: ADDITIONAL INFORMATION. PATIENT OUTCOME: ALL PATIENTS RECOVERING WITH NO CLINICALLY SIGNIFICANT VISION LOSS FROM THE EVENT. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT 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 WAS NOT PROVIDED. EXPIRATION DATE IS UNKNOWN AS LOT WAS NOT PROVIDED. MANUFACTURER DATE IS UNKNOWN AS LOT WAS NOT PROVIDED. (B)(4). A REVIEW OF RECORDS RELATED TO THE DEVICE INCLUDING LABELING, COMPLAINT TRENDING, AND RISK DOCUMENTATION COULD NOT BE PERFORMED AS THE PHACO TUBING PACK MODEL NUMBER AND LOT NUMBER WERE UNKNOWN. PRODUCT TESTING WAS NOT CONDUCTED AS DEVICE WAS NOT RETURNED; THEREFORE THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. BASED ON THE INFORMATION OBTAINED, THERE IS NO INDICATION OF A PRODUCT MALFUNCTION. JOHNSON & JOHNSON SURGICAL VISION WILL CONTINUE TO MONITOR THIS TYPE OF COMPLAINTS PER GLOBAL COMPLAINT TRENDING. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CATARACT PATIENTS PRESENTED WITH TOXIC ANTERIOR SEGMENT SYNDROME (TASS) AFTER USING PHACO HANDPIECE AND SIGNATURE DISPOSABLE TUBING PACKS. A BRIEF DESCRIPTION FROM THE SURGERY CENTER INDICATED THAT THEY HAVE HAD TWO CASES OF TASS. ATTEMPTS AT FOLLOW UP HAVE BEEN UNSUCCESSFUL AND NO ADDITIONAL INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT. THIS REPORT IS FOR THE TUBING PACK USED FOR THE 1ST UNIDENTIFIED PATIENT. A SEPARATE REPORT IS BEING SUBMITTED FOR THE HANDPIECE USED FOR THE PATIENT. ALSO SEPARATE REPORTS FOR HANDPIECE AND TUBING PACK WILL BE SUBMITTED FOR THE 2ND UNIDENTIFIED PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1395582 SIGNATURE PACK, DISPOSABLE TUBING PHACO TUBING HQC JOHNSON & JOHNSON SURGICAL VISION, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other COMPACT INTUITIV PHACO SYSTEM, SN UNKNOWN| COMPACT INTUITIV PHACO SYSTEM, SN UNKNOWN