BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR

    MDR report key: 7291499 · Received February 23, 2018

    Report

    Report Number
    3006695864-2018-00373
    Event Type
    Injury
    Date Received
    February 23, 2018
    Report Date
    April 12, 2018
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    LZS
    UDI-DI
    00(01)(21)3490
    PMA / PMN Number
    P930016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    APPLICATION SUPPORT MANAGER (ASM) VISITED THE ACCOUNT AND REPORTED NO ISSUES WERE OBSERVED. SYSTEM WAS CHECKED AND NO ISSUES WERE FOUND. SYSTEM MET SPECIFICATIONS. A MEDICAL AFFAIRS CLINICAL LEADERSHIP (MACL) REVIEW WAS CONDUCTED. IN THE PATIENT DATA PROVIDED IT WAS OBSERVED THAT THE PATIENT HAD CENTRAL UNDER ABLATION WHICH IS MOST LIKELY DUE TO A COMBINATION OF FACTORS. A POSSIBILITY IS BECAUSE THE LASER WAS OPERATED AT HIGHER ELEVATION (3250 FEET ABOVE SEA LEVEL) AND AT LOW HUMIDITY THE AMOUNT OF TISSUE PER PULSE IS MORE THAN NORMAL AND CAN LEAD TO THIS ISSUE. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    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 NOT SIGNIFICANT CHANGE OVER HISTORICAL COMPLAINT LIMITS AND NO RECOGNIZABLE ADVERSE TREND. THE RISKS AND MITIGATIONS 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS TREATED ON (B)(6) 2017 AND PRESENTED POST OP WITH CENTRAL ISLANDS IN BOTH EYES. AS OF 1 MONTH POST OP PATIENT HAS LOST TWO LINES ON THE RIGHT EYE AND ONE LINE ON THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136041 STAR EXCIMER LASER LZS ABBOTT MEDICAL OPTICS 0030-1479 00(01)(21)3490

    Patients

    Seq Age Sex Outcome Treatment
    1 Other