BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATALYST SYSTEM ROTARY VANE DOMESTIC

    MDR report key: 219285 · Received April 15, 1999

    Report

    Report Number
    2023366-1999-00013
    Event Type
    Injury
    Date Received
    April 15, 1999
    Date of Event
    March 15, 1999
    Report Date
    March 15, 1999
    Manufacturer
    CHIRON VISION CORP.
    Product Code
    HQC
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE MEDICAL DIRECTOR REPORTED THAT THE CATALYST UNIT DID NOT REGISTER VACUUM. AFTERWARD, THE ASPIRATION LEVEL WENT FROM ZERO VACUUM TO FULL VACUUM, THEN DELIVERED A SURGE OF VACUUM THROUGH THE TIP OF THE HANDPIECE. A CAPSULAR TEAR OCCURRED AND A VITRECTOMY PROCEDURE WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATALYST SYSTEM ROTARY VANE DOMESTIC EQUIPMENT HQC CHIRON VISION CORP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention