BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 1910384 · Received November 18, 2010

    Report

    Report Number
    2028159-2010-02239
    Event Type
    Injury
    Date Received
    November 18, 2010
    Date of Event
    October 19, 2010
    Report Date
    October 19, 2010
    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
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM. A SYSTEM MESSAGE WAS FOUND IN THE EVENT LOG. THE SOLENOID SPACERS WERE REPLACED BUT WERE DAMAGED WHEN REMOVED AND DISPOSED OF ON SITE. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    A DOCTOR REPORTED DURING THE CASE, A CAPSULAR RUPTURE OCCURRED. THE PROCEDURE COULD BE COMPLETED BY IMPLANTING ANOTHER TYPE OF LENS. ADDITIONAL INFORMATION WAS REQUESTED. ADDITIONAL INFORMATION RECEIVED FROM THE SURGEON INDICATED DURING THE CASE SUDDENLY NO MORE FLUID WAS GOING INTO THE EYE, BUT FLUID WAS STILL BEING ASPIRATED. THIS RESULTED IN THE ANTERIOR CHAMBER COMPLETELY FLATTENING. AFTER FILLING THE EYE WITH VISCOELASTIC MATERIAL, IT APPEARED THAT A CAPSULAR RUPTURE HAD OCCURRED WITH LOSS OF VITREOUS. WITH DIFFICULTY, THE SURGEON WAS ABLE TO GET THE REMAINING NUCLEUS OUT OF THE EYE, PERFORMED AN ANTERIOR VITRECTOMY, AND IMPLANTED A SULCUS LENS. THE DAY AFTER SURGERY, IT APPEARED THAT THERE WAS VITREOUS REMAINING IN THE ANTERIOR CHAMBER AND SERIOUSLY INCREASED INTRAOCULAR PRESSURE ALTHOUGH, A DIAMOX HAD BEEN GIVEN. THE PT WAS THEN REFERRED TO THE POSTERIOR SEGMENT DEPARTMENT OF THE HOSPITAL WHERE THE ISSUE WAS RESOLVED. THE REMAINING EIGHT SURGERIES WERE CANCELED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention