BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR

    MDR report key: 8647936 · Received May 28, 2019

    Report

    Report Number
    3006695864-2019-00428
    Event Type
    Injury
    Date Received
    May 28, 2019
    Date of Event
    October 26, 2018
    Report Date
    November 6, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    LZS
    UDI-DI
    00(01)(21)3297
    PMA / PMN Number
    P930016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CORRECTION MDR IS BEING SUBMITTED TO ADDRESS INACCURATE INFORMATION IN SECTION F ON THE XML VERSION OF THE PREVIOUS SUBMISSION CAUSED BY A SOFTWARE GLITCH IN THE TRANSMISSION PROCESS. THE INTERNAL NON-CONFORMANCE NUMBERS FOR THIS SOFTWARE ISSUE ARE NR-0148919 AND CAPA-010215.

    Additional Manufacturer Narrative · 1

    (B)(6). THE REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR EXCIMER (S/N (B)(4)) SHOWED NO ISSUES OR NONCONFORMANCES. THE SYSTEM AND ITS COMPONENTS MET ALL SPECIFICATIONS PRIOR TO BEING RELEASED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT PATIENT HAD DIFFUSE LAMELLAR KERATITIS (DLK) OF UNKNOWN GRADE THAT DID NOT REQUIRED INTERVENTION. ON (B)(6) 2019 IT WAS REPORTED THAT PATIENT PRESENTED WITH MILD DLK AT ONE DAY THAT REQUIRED INCREASE IN STEROIDS (PREDFORTE) MEDICATION EVERY 2 HOURS. AT 4 DAYS POST OP HAD DLK STAGE 2 (RIGHT) STAGE 3 (LEFT) AND PREDFORTE MEDICATION WAS INCREASED TO HOURLY. AT 5 DAYS DLK PROGRESSED (STAGE 2-3 RIGHT EYE AND STAGE 4 IN LEFT EYE) AND PATIENT WAS GIVEN DOXYCYCLINE (1 TAB). PATIENT WAS SEEN IN (B)(6) AND HAD HAZE; PATIENT CONTINUED MEDICATION. ON (B)(6) PATIENT HAZE WAS CONSOLIDATING AND PREDFORTE WAS GIVEN FOR EVERY 2 HOURS WITH DOXYCYCLINE AND VITAMIN C 1GM (BOTH) IN RIGHT EYE. ON (B)(6) PATIENT PRESENTED WITH MILD HAZE (RIGHT) AND CENTRAL HAZE (LEFT) CONSOLIDATING WITH PREDFORTE EVERY 3 HOURS AND DOXYCYCLINE IN RIGHT EYE AND VITAMIN C. ON (B)(6) PATIENT PRESENTED WITH MILD HAZE (RIGHT) AND HAZE +2 (LEFT) AND PREDFORTE WAS CHANGED TO 4 TIMES A DAY. ON (B)(6) THE PATIENT PRESENTED WITH MILD HAZE (RIGHT) AND HAZE IMPROVING (LEFT) AND PATIENT WAS GIVEN TAPER PREDFORTE AND BY (B)(6) THERE WAS MILD HAZE AND PREDFORTE WAS STOP AND FML (FLUOROMETHOLONE) EYE DROPS WERE GIVEN 4 TIMES A DAY. ON (B)(6) PATIENT¿S CORNEA WAS CLEAR (RIGHT) AND MILD HAZE (LEFT) WAS OBSERVED AND FML DROPS WERE STOP IN RIGHT EYE AND IN LEFT EYE WERE GIVEN 3 TIMES A DAY. ON (B)(6) 2019 CORNEA WAS CLEAR IN RIGHT EYE AND LEFT EYE HAD TAPER FML DROPS. PATIENT WAS SEEN ON (B)(6) AND CORNEA WERE CLEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439626 STAR EXCIMER LASER LZS JOHNSON & JOHNSON SURGICAL VISION, INC. 0030-1479 00(01)(21)3297

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention