BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES TWENTY THOUSAND LEGACY

    MDR report key: 113087 · Received August 12, 1997

    Report

    Report Number
    2028159-1997-00128
    Event Type
    Injury
    Date Received
    August 12, 1997
    Date of Event
    July 15, 1997
    Report Date
    July 15, 1997
    Manufacturer
    ALCON LABORATORIES
    Product Code
    HQE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    H-10: CUSTOMER RETURNED PT (B) QUESTIONNAIRE FOLLOWING COMPANY REP'S VISIT. H-11: REVISED ITEMS A1, A2, A3, A4, B5, B7. THIS REPORT WAS MAILED IN TO FDA ON: 9/12/97. THE MFRS INTERNAL REFERENCE NUMBER IS: 7-9954B-1-97. THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN ALCON LABORATORIES, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

    H-10: CUSTOMER RETURNED PT (A) QUESTIONNAIRE FOLLOWING COMPANY REP'S VISIT. H-11: REVISED ITEMS A1, A2, A3, B3, B5, B7. THIS REPORT WAS MAILED IN TO FDA ON: 9/12/97. THE MFRS INTERNAL REFERENCE NUMBER IS: 7-9954A-1-97. THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN ALCON LABORATORIES, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

    Description of Event or Problem · 1

    PT (A) PROGNOSIS WAS REPORTED AS GOOD.

    Description of Event or Problem · 1

    PT (B) PROGNOSIS REPORTED AS GOOD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention