BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR

    MDR report key: 7679614 · Received July 11, 2018

    Report

    Report Number
    3006695864-2018-01481
    Event Type
    Injury
    Date Received
    July 11, 2018
    Date of Event
    June 7, 2018
    Report Date
    October 30, 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

    DEVICE EVALUATION: A REVIEW OF THE RECORDS RELATED TO THE DEVICE THAT INCLUDED LABELING, MANUALS, TRENDING, AND RISK DOCUMENTATION WAS PERFORMED. THE TREND REVIEW SHOWS THAT THERE IS NO SIGNIFICANT CHANGE OVER HISTORICAL COMPLAINT LIMITS AND NO RECOGNIZABLE ADVERSE TREND. THE RISKS AND MITIGATION'S ASSOCIATED WITH THE COMPLAINT ISSUE ARE IDENTIFIED IN EXISTING RISK DOCUMENTS AND NO NEW RISKS WERE IDENTIFIED AS PART OF THIS INVESTIGATION. THERE WAS NO PRODUCT DEFICIENCY IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    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) MANUFACTURING DATE REQUESTED BUT NOT AVAILABLE AT THE TIME OF THIS REPORT. A REVIEW OF RECORDS RELATED TO THE DEVICE INCLUDING LABELING, COMPLAINT TRENDING, AND RISK DOCUMENTATION WILL BE PERFORMED. UPON COMPLETION OF THIS REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4) ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED A SURGEON DID IRIS REGISTRATION SEVERAL TIMES FOR A BILATERAL CUSTOMVUE LASIK BUT STILL HE WAS NOT ABLE TO GET ACQUIRE IT. HE THEN MOISTENED THE CORNEAL STROMA WITH BALANCED SALT SOLUTION AND WAS ABLE TO GET IRIS REGISTRATION. LASER TREATMENT (ABLATION) WAS DONE. AT ONE DAY POST TREATMENT VISION IN THAT EYE WAS 6/15. SURGEON REPORTED THAT WHEN HE SAW THE PATIENT FOR NEXT FOLLOW UP, THE VISION DROPPED TO 6/30. SURGEON WAS UNABLE TO CAPTURE TOPOGRAPHY OR IDESIGN MAPS DURING THAT VISIT. CORNEA IS QUIET. SURGEON REPORTED BEING CONCERNED THAT STROMA WAS NOT DRY ENOUGH AND THAT CAUSED IRREGULAR ABLATION POTENTIALLY CAUSING CENTRAL ISLAND. PATIENT IS CURRENTLY 6/12 WITH A LOT OF GLARE AND A SLIGHT CHANGE IN THE TOPOGRAPHY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519575 STAR EXCIMER LASER LZS JOHNSON & JOHNSON SURGICAL VISION, INC 0030-1479 00(01)(21)3297

    Patients

    Seq Age Sex Outcome Treatment
    1 Other