BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STORZ PREMIERE

    MDR report key: 156072 · Received March 13, 1998

    Report

    Report Number
    156072
    Event Type
    Injury
    Date Received
    March 13, 1998
    Date of Event
    October 6, 1997
    Report Date
    March 4, 1998
    Manufacturer
    STORZ INSTRUMENT CO.
    Product Code
    HQC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT HAD CATARACT SURGERY (PHACO W/IOL OD) W/ VITRECTOMY: REPORTEDLY, THE PREMIERE PHACO MACHINE) WAS LESS THAN EXPECTED, SO THE POWER WAS PROGRESSIVELY INCREASED, WITH UNEXPECTED SUDDEN JUMPS IN ASPIRATING POWER. PT. WAS HOSPITALIZED 11/4/97 WITH ENDOPHTHALMITIS (SHE PRESENTED WITH PAIN & DECREASED VISION). OPHTHALMOLOGIST REPORTS VISION IS 20/100.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STORZ PREMIERE IRRIGATOR/ASPIRATOR/PHACO HQC STORZ INSTRUMENT CO. DP1402 200 *

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| O| R