BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERSAL II

    MDR report key: 796615 · Received December 16, 2006

    Report

    Report Number
    2028159-2006-00505
    Event Type
    Injury
    Date Received
    December 16, 2006
    Date of Event
    October 30, 2006
    Report Date
    November 16, 2006
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CTR
    Product Code
    HQE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION, INCLUDING ROOT CAUSE ANALYSIS, IS IN PROGRESS.

    Description of Event or Problem · 1

    A DOCTOR INITIALLY REPORTED GROWTH OF PSEUDOMONAS AERUGINOSA FROM PIECE OF (SYSTEM'S) INTERNAL TUBES IN MICROBIOLOGICAL MEDIUM, POTENTIALLY CAUSING EYE INFLAMMATION. INITIAL REPORT WAS FILED AS MFG. RPT. # 2028159-2006-00493. 11/16/2006: ADDITIONAL INFORMATION RECEIVED FROM THE DOCTOR NOTED THERE WERE TEN CASES OCCURRING BETWEEN 10/2006 AND 11/2006. THESE ADDITIONAL 9 CASES REPORTED AS MFG. RPT. #: 2028159-2006-00502, 2028159-2006-00503, 2028159-2006-00504, 2028159-2006-00505, 2028159-2006-00506, 2028159-2006-00507, 2028159-2006-00508, 202815-2006-00509, 2028159-2006-00510. NO CULTURES WERE DONE BECAUSE IN NORMAL PROCEDURE THE PATIENT IS TAKING ANTIBIOTICS AFTER SURGERY. THE INFLAMMATION OCCURRED THREE TO FOUR HOURS AFTER SURGERY. 11/28/2006: ADDITIONAL INFORMATION FROM THE DOCTOR INDICATED HAD: "CORNEAL EDEMA. ANTERIOR CHAMBER FILLED WITH NUMEROUS INFLAMMATORY CELLS. FIBRINOUS MEMBRANES PROLIFERATING IN THE PUPILLARY APERTURE EXTEND TO THE IRIS AND TOUCH THE CORNEA WITH DIGITATE PROCESSES. IN THE ANTERIOR CHAMBER A CONGLOMERATE OF GELATINOUS TISSUE LOCATED IN PROJECTION OF THE PUPILLARY APERTURE." THIS WAS REASON FOR PROLONGED HOSPITALIZATION. NORMAL STAY IS ONE DAY. THIS PATIENT'S EVENT DURATION WAS 4 DAYS. OUTCOME IS GOOD. THERE WAS NO UNPLANNED MEDICAL OR SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL II PHACOEMULSIFICATION-ASPIRATION SYSTEM HQE ALCON - IRVINE TECHNOLOGY CTR UNIV II PEA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization