BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 3231557 · Received July 15, 2013

    Report

    Report Number
    2028159-2013-01452
    Event Type
    Injury
    Date Received
    July 15, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 17, 2013
    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
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER 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. 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. A ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT A POSTERIOR CAPSULAR TEAR (PC TEAR) OCCURRED. NO VITRECTOMY WAS NEEDED AND THE INTRAOCULAR LENS WAS IMPLANTED SUCCESSFULLY. ADDITIONAL INFORMATION WAS RECEIVED FROM A CLINICAL APPLICATIONS SPECIALIST INDICATING THAT A RADIAL TEAR WAS SEEN AT 2 O'CLOCK AND DID NOT EXTEND BEYOND THE EQUATOR. THERE WAS NO VITREOUS LOSS AND NO ANTERIOR VITRECTOMY WAS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327656 INFINITI VISION SYSTEM OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other LENSX LASER SYSTEM| SN6AD1 (RESTOR)