BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 3133028 · Received May 24, 2013

    Report

    Report Number
    2028159-2013-00984
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    April 29, 2013
    Report Date
    April 29, 2013
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CTR
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLES WERE RETURNED FOR EVAL FOR "POSTERIOR CAPSULAR RUPTURE". NO LOT NUMBER WAS IDENTIFIED WITH THIS COMPLAINT; THEREFORE, A LOT HISTORY REVIEW COULD NOT BE CONDUCTED. THE ROOT CAUSE FOR "POSTERIOR CAPSULAR RUPTURE" CANNOT BE DETERMINED FROM THIS EVAL. HOWEVER, THE SURGEON STATED 'HE FEELS CONFIDENT THAT WHILST REMOVING THE FIRST QUADRANT, HE CAUGHT THE POSTERIOR CAPSULE WITH THE PHACO TIP'. ALL PHACO TIPS ARE 100% VISUALLY INSPECTED PRIOR TO THEIR RELEASE. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT DURING A CATARACT WITH INTRAOCULAR LENS IMPLANT PROCEDURE, HE CAUGHT THE POSTERIOR CAPSULE WITH THE PHACO TIP WHILE REMOVING THE FIRST QUADRANT AND THE PT EXPERIENCED A POSTERIOR CAPSULAR RUPTURE REQUIRING A VITRECTOMY. AN INTRAOCULAR LENS WAS INSERTED INTO THE SULCUS AND THE PT WAS REFERRED TO A VITREO-RETINAL SPECIALIST THE SAME AFTERNOON FOR RECOVERY OF THE DROPPED LENS. THE PT'S CONDITION WAS REPORTED TO HAVE RESOLVED WITH THE TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231804 INFINITI VISION SYSTEM OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CTR INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention LENSX LASER