BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2842003 · Received November 14, 2012

    Report

    Report Number
    2028159-2012-01828
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    October 15, 2012
    Report Date
    October 15, 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
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY CLINICAL ANALYST REVIEWED THE FILE AND NOTED: THE TWO MAIN CAUSES FOR CAPSULE RUPTURE ARE PREDISPOSING LENS AND PT FACTORS THAT MAKE THE CAPSULE FRAGILE AND EASY TO BREAK AND/OR INADEQUATE/IMPROPER SURGICAL MANEUVERS/CONSOLE SETTINGS THAT PRODUCE THE RUPTURE. THERE IS INSUFFICIENT INFO TO CONCLUDE THAT THE INTEGRITY OF THE POSTERIOR CAPSULE WAS AFFECTED BY THE PERFORMANCE OF THE SYSTEM OR OTHER SURGICAL FACTORS PRESENT AT THE TIME. THE SURGEON STATED THAT NO ALCON PRODUCT CONTRIBUTED TO THE REPORTED EVENT. THE FACILITY DID NOT REQUEST SERVICE. THERE WAS NO SAMPLE RETURNED FOR EVAL AND NO ADDITIONAL INFO PROVIDED RELATED TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID NOT INDICATE ANY ADDITIONAL SIMILAR REPORTS FOR THIS SYSTEM. THE ROOT CAUSE OF THE PT EVENT CANNOT BE DETERMINED IN THIS INVESTIGATION. POSTERIOR CAPSULE TEAR IS AN ISSUE THAT IS OCCASIONALLY REPORTED WITH CATARACT SURGERY. HOWEVER, A REVIEW OF THE COMPLAINT TRENDS SHOWS THAT THE FREQUENCY REPORTED IS WITHIN KNOWN LEVELS FOR THIS EVENT. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT A SMALL POSTERIOR CAPSULAR HOLE WAS NOTED, DURING A PROCEDURE, AFTER THE PHACO TIP CAME IN CONTACT WITH THE POSTERIOR CAPSULE. THERE WAS NO VITREOUS LOSS, THE INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE BAG, AND THE PROCEDURE WAS ABLE TO BE COMPLETED WITH NO IMPACT TO THE PT. OPTICAL COHERENCE TOMOGRAPHY (OCT) TESTS COULD NOT COMPLETE A SCAN OF THE LENS FOR THE LENSX PROCEDURE DUE TO THE PT HAVING A MATURE CATARACT. THE LENSX SYSTEM PERFORMED ONLY THE CAPSULOTOMY. ADDITIONAL INFO WAS RECEIVED FROM THE SURGEON INDICATING THAT NO ALCON PRODUCT CONTRIBUTED TO THE REPORTED EVENT.

    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 75 YR Other