BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2003647 · Received February 24, 2011

    Report

    Report Number
    2028159-2011-00172
    Event Type
    Injury
    Date Received
    February 24, 2011
    Report Date
    December 16, 2010
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CTR
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE IS EXPECTED TO RETURN FOR EVAL. INVESTIGATION, INCLUDING ROOT CAUSE ANALYSIS, IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WHEN ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    AN EYE SURGERY CENTER REPRESENTATIVE INITIALLY NOTIFIED THE COMPANY VIA RETURNED REPLY CARD THAT THERE WAS A FOLDING ISSUE WITH AN INTRAOCULAR LENS AND A POSTERIOR CAPSULE TEAR. ADDITIONAL INFO RECEIVED FROM THE OPERATING ROOM NURSE MANAGER, INDICATED THAT ACCORDING TO THE CHART THE INTRAOCULAR LENS WAS IMPLANTED WITHOUT AN ISSUE. THERE WAS NO FOLDING PROBLEM. SHE REPORTED DURING IA (IRRIGATION/ASPIRATION) TO REMOVE THE VISCOELASTIC, THE POSTERIOR CAPSULE RUPTURED. VITRECTOMY WAS REQUIRED. SHE STATED THE INTRAOCULAR LENS WAS CUT OUT, THE INCISION WAS ENLARGED AND THE LENS REMOVED. SHE STATED AT THAT TIME A DIFFERENT INTRAOCULAR LENS WAS INSERTED IN THE SULCUS. SHE IS UNSURE OF THE PT'S OUTCOME. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention MA60AC| MONARCH II HANDPIECE| SN60WF| MONARCH C CARTRIDGE| VISCOAT