BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 2192453 · Received July 27, 2011

    Report

    Report Number
    2028159-2011-00855
    Event Type
    Injury
    Date Received
    July 27, 2011
    Report Date
    June 27, 2011
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K021566
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CALLED THE COMPANY TECHNICAL SUPPORT SPECIALIST (TSS) TO COMPLAIN OF TOO MUCH FLOW. THE CUSTOMER REPORTED THEY LOWERED THE BOTTLE PER RECOMMENDATION FROM THE COMPANY SALES REP AND HAVE HAD NO FURTHER PROBLEMS. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID NOT INDICATE ANY ADDITIONAL SIMILAR REPORTS FOR THIS SYSTEM. THE ROOT CAUSE FOR THE REPORTED EVENT "EXCESSIVE FLOW" IS A SYSTEM SETTINGS ISSUES (RELATED TO BOTTLE HEIGHT) SINCE THE REPORTED EVENT WAS ADDRESSED AFTER SYSTEM SETTINGS MODIFICATION. POSTERIOR CAPSULE TEAR IS AN ISSUE THAT IS OCCASIONALLY REPORTED WITH CATARACT SURGERY. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REQUESTED THAT THE SETTINGS ON THEIR SYSTEM BE CHANGED TO REDUCE FLOW BECAUSE TWO PTS EXPERIENCED A POSTERIOR CAPSULE TEAR, AND ONE PT'S NUCLEUS SHATTERED DURING CATARACT EXTRACTION SURGERY. IN A F/U, THE SURGEON INDICATED THAT HE LIKES TO PHACO WITH A LOT OF POWER. HE MANUALLY CHANGED THE POWER AND THE FLOW BECAME TOO GREAT. ALL THREE CASES WERE COMPLETED WITHOUT FURTHER INCIDENT AND SUCCESSFUL INTRAOCULAR LENS IMPLANTATION. THERE WAS NO PT INJURY REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED.

    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 Required Intervention