BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2924853 · Received January 17, 2013

    Report

    Report Number
    2028159-2013-00059
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    November 13, 2012
    Report Date
    November 16, 2012
    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
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE EXAMINED THE SYSTEM AND FOUND THAT THE CUSTOMER'S PHACO HANDPIECE (HP) WAS NOT DETECTED BY THE SYSTEM AND THE HP'S LOG WAS NOT ABLE TO BE RETRIEVED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. THE PHACO HANDPIECE WAS RECEIVED AND A VISUAL ASSESSMENT OF THE RETURNED SAMPLE DID NOT REVEAL ANY NONCONFORMITY. THE PHACO HANDPIECE WAS TESTED AND PASSED ALL TESTING. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID NOT INDICATE ANY ADDITIONAL SIMILAR REPORTS FOR THIS PHACO HANDPIECE OR SYSTEM. A QUESTIONNAIRE WAS SENT TO THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION. THE QUESTIONNAIRE WAS COMPLETED AND RETURNED. THE RETURNED QUESTIONNAIRE WAS REVIEWED BY A COMPANY CLINICAL ANALYST, AND UPON REVIEW OF THE FILE AND QUESTIONNAIRE, THE CLINICAL ANALYST STATED THE FOLLOWING: IN THE RETURNED QUESTIONNAIRE, IT WAS STATED THAT THE CUSTOMER BELIEVES THE PRODUCT CONTRIBUTED TO THE OCCURRENCE OF CORNEAL BURN WHICH THEN COMPLICATED THE SURGERY WITH "RUPTURE AT THE IRIS BASIS" (PER ENGLISH TRANSLATION). THERE WAS NO FURTHER EXPLANATION OR DETAILS WHY IT WAS BELIEVED BY THE CUSTOMER THAT THE PRODUCT CONTRIBUTED OR DIRECTLY CAUSED THE CORNEAL THERMAL INJURY. CORNEAL BURN IS AN ISSUE THAT IS OCCASIONALLY REPORTED WITH CATARACT SURGERY. ACCORDING TO THE PENNSYLVANIA PATIENT SAFETY ADVISORY ABSTRACT: PREVENTING CORNEAL BURNS DURING PHACOEMULSIFICATION, MARCH 2010, VOL. 7, NO. 1: 23-25, MOST CORNEAL BURNS CAN BE TRACED TO ISSUES RELATED TO SURGICAL TECHNIQUE AND NOT TO MALFUNCTIONING EQUIPMENT. A ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT DURING THE PHACOEMULSIFICATION STEP OF A CATARACT WITH INTRAOCULAR LENS IMPLANT PROCEDURE, THE LENS CORE BECAME COMPLETELY WHITE AT THE TIP AND WAS NOT ENTIRELY DISSOLVED; SUBSEQUENTLY, A CORNEAL BURN OCCURRED. THE SURGEON NOTED THAT IT WAS A COMPLICATED SURGERY WITH "RUPTURE AT THE IRIS BASIS". A SUTURE WAS PLACED AT THE CORNEAL AND THE PATIENT WAS HOSPITALIZED FROM ON (B)(6) 2012 AS A RESULT OF THE EVENT. IT WAS REPORTED THAT THE PATIENT'S CONDITION HAD NOT YET RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26932 INFINITI VISION SYSTEM OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON- IRVINE TECHNOLOGY CENTER INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R DISCOVISC| OZIL TORSIONAL PHACO HANDPIECE