BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES TWENTY THOUSAND LEGACY & ACCESSORIES

    MDR report key: 58858 · Received December 20, 1996

    Report

    Report Number
    2028159-1996-00222
    Event Type
    Injury
    Date Received
    December 20, 1996
    Date of Event
    December 2, 1996
    Report Date
    December 2, 1996
    Manufacturer
    ALCON LABORATORIES
    Product Code
    HQE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    H-10: ADDITIONAL PATIENT INFO RECEIVED FROM FOLLOW-UP QUESTIONNAIRE: SECTION B-6 & 7. EVALUATION ADDED: NO CONSUMABLES WERE SAVED FOR EVALUATION. A COMPANY SERVICE REP. CHECKED THE SYSTEM AND HANDPIECE, S/N IUHP 183243, AND FOUND THEM BOTH TO MEET PERFORMANCE SPECIFICATIONS. UNABLE TO DUPLICATE PROBLEM REPORTED. PROBLEM REPORTED WAS NOT RELATED TO EVENT. H-11: SECTION A-3: 69.

    Description of Event or Problem · 1

    REPORTER NOTED CORNEAL BURN DURING PROCEDURE. CONVERT FROM SUPERIOR TO TEMPORAL INCISION; CHANGED HANDPIECE TO CONTINUE PHACO. SUTURES NEEDED TO CLOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERIES TWENTY THOUSAND LEGACY & ACCESSORIES OPHTHALMIC SURGERY SYSTEM - HANDPIECE HQE ALCON LABORATORIES STTL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention