BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 2160811 · Received July 7, 2011

    Report

    Report Number
    2028159-2011-00769
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    May 17, 2011
    Report Date
    June 7, 2011
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K021566
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY DID NOT REQUEST SERVICE. NO SAMPLES WERE RETURNED FOR EVALUATION. THERE WAS NO SAMPLE RETURNED FOR EVALUATION AND NO ADDITIONAL INFORMATION PROVIDED RELATED TO THIS EVENT. A ROOT CAUSE HAS NOT BEEN IDENTIFIED. CORNEAL BURN IS AN ISSUE THAT IS OCCASIONALLY REPORTED WITH CATARACT SURGERY. ACCORDING TO THE (B)(6) PATIENT SAFETY ADVISORY ABSTRACT: PREVENTING CORNEAL BURNS DURING PHACOEMULSIFICATION, (B)(6) 2010, VOL. 7, NO.1: 23-25, MOST CORNEAL BURNS CAN BE TRACED TO ISSUES RELATED TO SURGICAL TECHNIQUE AND NOT TO MALFUNCTIONING EQUIPMENT. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED A PATIENT RECEIVED A CORNEAL BURN. THIS EVENT RESULTED IN SEVEN SUTURES WHICH HAS CAUSED 'SIGNIFICANT INDUCED ASTIGMATISM" AND EDEMA. ADDITIONAL INFORMATION WAS RECEIVED IN A COMPLETED QUESTIONNAIRE REPORTING A CORNEAL BURN WAS OBSERVED AT THE BEGINNING OF A PHACOEMULSIFICATION PROCEDURE DUE TO AN OCCLUSION. THE REPORTED BURN REQUIRED SEVERAL SUTURES FOR CLOSURE. IT WAS REPORTED THAT THE ASTIGMATISM WILL PROBABLY PERSIST.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention OZIL TORSIONAL PHACO HANDPIECE| VISCOAT