BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 2930409 · Received January 23, 2013

    Report

    Report Number
    2028159-2013-00100
    Event Type
    Injury
    Date Received
    January 23, 2013
    Date of Event
    December 20, 2012
    Report Date
    December 25, 2012
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K021566
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A PT EXPERIENCED A POSTERIOR CAPSULE (PC) TEAR DURING THE POLISHING PHASE OF CATARACT SURGERY. THE SURGEON REPORTED THE TEAR WAS CAUSED BY A "BUMP" ON THE I/A (IRRIGATION/ASPIRATION) TIP. ADD'L INFO PROVIDED FROM THE SURGEON INDICATED "THIN POSTERIOR CHAMBER WAS CONSIDERED AS AN OTHER REASON OF PC TEAR. I THOUGHT THE ROOT CAUSE OF THE PC TEAR WAS THE SHAPE OF THE I/A TIP, BUT I BELIEVED THE MOVIE OF THE OPERATION; I THOUGHT THE TEAR WAS CAUSED BY THE FORCE PULLING SIDEWAY OF THE POSTERIOR CAPSULE." THERE WAS NO TREATMENT REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32936 INFINITI VISION SYSTEM PHACOGRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other SINGLE USE STRAIGHT I/A TIP