BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 4101688 · Received September 15, 2014

    Report

    Report Number
    2028159-2014-01693
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    August 19, 2014
    Report Date
    August 21, 2014
    Manufacturer
    ALCON ¿ IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K112425
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM WAS EXAMINED AND THE REPORTED EVENT WAS REPLICATED. FLUIDICS MECHANISM WAS REPLACED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. A REVIEW OF THE CUSTOMER'S COMPLAINT HISTORY FOR THE LAST 24 MONTHS DID NOT SHOW ANY PREVIOUS COMPLAINTS OF THIS KIND AGAINST THE SYSTEM. THE SYSTEM WAS MANUFACTURED ON 10/11/2013. A REVIEW OF THE MANUFACTURING RECORDS DID NOT REVEAL ANY SIMILAR NON-CONFORMITY DURING MANUFACTURING FOR THIS PRODUCT. BASED ON QA ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. THE ROOT CAUSE IS SUSPECTED TO BE ATTRIBUTED TO A NONCONFORMING FLUIDICS MECHANISM. HOWEVER, COMPONENT LEVEL ROOT CAUSE REMAINS UNKNOWN WITH THE CURRENT INFORMATION OBTAINED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A FLUIDICS SYSTEM MESSAGE DISPLAYED AND THE SYSTEM LOCKED DURING HIS FIRST CATARACT CASE OF THE DAY. THE SYSTEM WAS EXCHANGED TO COMPLETE THE CASE. THE PROCEDURE WAS PERFORMED WITH A MANUAL EXTRA CAPSULAR CATARACT EXTRACTION INSTEAD OF USING PHACOEMULSIFICATION. THE PATIENT EXPERIENCED A RUPTURE OF THE ZINN'S ZONULES. THE PATIENT IS RECOVERING AND THE INTRAOCULAR LENS IS SCHEDULED FOR PLACEMENT AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570102 INFINITI VISION SYSTEM PHACOFRAGMENTATION SYSTEM HQC ALCON ¿ IRVINE TECHNOLOGY CENTER INFINITI V3.0 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other