BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IDESIGN RS

    MDR report key: 18457492 · Received January 5, 2024

    Report

    Report Number
    3012236936-2024-00055
    Event Type
    Injury
    Date Received
    January 5, 2024
    Report Date
    February 15, 2024
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    LZS
    PMA / PMN Number
    P930016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: H4: IN INITIAL REPORT, THE MANUFACTURER DATE PROVIDED WAS INADVERTENTLY REPORTED AS JULY 1, 2021, HOWEVER THE CORRECT DATE IS JULY 24, 2021. ADDITIONAL INFORMATION: MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE DEVICE WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: APPLICATION SUPPORT MANAGER (ASM) SPOKE WITH DOCTOR REGARDING THE PROCEDURES IN WHICH ENHANCEMENTS WERE PERFORMED. DOCTOR REPORTED THAT ALL BUT ONE WERE BILATERAL ENHANCEMENTS. HE WAS NOT ABLE TO PROVIDE THE DATES OR PATIENT DEMOGRAPHICS. NO ADDITIONAL INFORMATION WAS PROVIDED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION A2 : THE ACCURATE AGE WASN'T PROVIDED BUT THE PATIENT'S AGE IS 40 YEARS OLD AND OLDER. DEVICE EVALUATION: A FIELD SERVICE ENGINEER (FSE) VISITED SITE TO SERVICE THE SYSTEM AND FOUND NO ISSUES IN RELATIONSHIP TO THE OVERCORRECTION. THE SYSTEM IS PERFORMING TO SPECIFICATION. AN APPLICATION SUPPORT MANAGER (ASM) ALSO VISITED SITE AND REPORTED THAT THE OVERCORRECTION WAS A RESULT OF DOCTOR'S TRAINING. ASM PROVIDED ADDITIONAL TRAINING AND RECOMMENDATIONS TO AVOID GETTING OVERCORRECTIONS. 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. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT WAS OVERCORRECTED WITH NO MORE THAN 1 DIOPTER AND AN ENHANCEMENT WAS PERFORMED. NO LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA) AND NO PATIENT INJURY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    986082 IDESIGN RS EXCIMER LASER SYSTEM LZS AMO MANUFACTURING USA, LLC G301

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention