BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION OZIL

    MDR report key: 3951830 · Received July 2, 2014

    Report

    Report Number
    2028159-2014-01238
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 3, 2014
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITION REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4). THIS REPORT WAS MAILED TO FDA ON: 07/03/2014. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A PATIENT PRESENTED WITH TASS (TOXIC ANTERIOR SEGMENT SYNDROME) IN THE RIGHT EYE, ON ONE DAY POST OP OF A CATARACT PROCEDURE. THE SURGEON INDICATED HE DID NOT KNOW THE ROOT CAUSE OF THE INCIDENT. A NURSE SITE VISIT WAS REQUESTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385690 INFINITI VISION OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other TOBRAMYCIN| ECONOPRED| DUOVISC| BALANCED SALT SOLUTION| TETRACAINE| PILOCARPINE 2%| SN6OWF| VANCOMYCIN| OZIL TORSIONAL PHACO HANDPIECE| LIDOCAINE/EPINEPHRINE