BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2945004 · Received February 4, 2013

    Report

    Report Number
    2028159-2013-00171
    Event Type
    Injury
    Date Received
    February 4, 2013
    Date of Event
    September 1, 2010
    Report Date
    January 5, 2013
    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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A LITERATURE ARTICLE REPORTED THAT THEIR SYSTEM WAS USED FOR A CATARACT PROCEDURE IN WHICH RETAINED LENS MATERIAL WAS NOTED IN THE POSTERIOR SEGMENT FOLLOWING THE PROCEDURE. THE LENS MATERIAL WAS REMOVED VIA A PARS PLANA VITRECTOMY USING A PHACOEMULSIFICATION HANDPIECE. A COMPANY CLINICAL ANALYST REVIEWED THIS FILE AS WELL AS THE ATTACHED REPORT AND STATED THE FOLLOWING. " THE AUTHOR DOES NOT SPECIFY THE EQUIPMENT USED IN THE CATARACT EXTRACTIONS LEADING TO THE SECONDARY REMOVAL OF RETAINED LENS MATERIAL PROCEDURE, THEREFORE PRODUCT USED, MANUFACTURER AND MODEL ARE UNKNOWN." ACCORDING TO THE AUTHOR, SURGICAL EQUIPMENT IS NOT INCLUDED IN FACTORS CONTRIBUTING TO RETAINED LENS MATERIAL. THERE WAS NO SAMPLE RETURNED FOR EVALUATION AND NO ADDITIONAL INFORMATION PROVIDED RELATED TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT. THE ROOT CAUSE COULD NOT BE DETERMINED CONCLUSIVELY; HOWEVER IT IS NOT RELATED TO USE OF THE SYSTEM. (B)(4).

    Description of Event or Problem · 1

    IN A LITERATURE REPORT WRITTEN ON A COMPARISON OF DEVICES TO REMOVE RETAINED LENS MATERIAL, 34 PATIENTS WERE IDENTIFIED AS HAVING REQUIRED PARS PLANA VITRECTOMY PROCEDURES TO REMOVE LENS MATERIAL FOLLOWING COMPLICATED CATARACT SURGERY OR TRAUMATIC/SPONTANEOUS LENS DISLOCATION. THIS REPORT REPRESENTS ONE IDENTIFIED PATIENT. THE SECONDARY PROCEDURE WAS PERFORMED TWO DAYS AFTER THE INITIAL CATARACT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46871 INFINITI VISION SYSTEM OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON- IRVINE TECHNOLOGY CENTER INFINITI OZIL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention (B)(4)| OZIL TORSIONAL PHACOEMULSIFICATION HANDPIECE