BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2161837 · Received July 8, 2011

    Report

    Report Number
    2028159-2011-00795
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 9, 2011
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CTR
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY DID NOT REQUEST SERVICE. THERE WAS NO SAMPLE RETURNED FOR EVALUATION AND NO ADDITIONAL INFORMATION PROVIDED RELATED TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT. THE ROOT CAUSE IS UNKNOWN AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT DURING SURGERY, THERE WAS A SIGNIFICANT SURGE DURING CORTEX REMOVAL AND THE SURGEON WAS UNABLE TO BACKFLUSH. THE POSTERIOR CAPSULE TORE. THE REMAINING CORTICAL MATERIAL WAS REMOVED MANUALLY, AND THE INTRAOCULAR LENS WAS IMPLANTED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT'S REFRACTION ON THE FIRST POSTOPERATIVE DAY WAS 20/400 WITH PLANO.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention BALANCED SALT SOLUTION, DUOVISC