BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR S4-IR-CE EXCIMER LASER

    MDR report key: 3170981 · Received June 14, 2013

    Report

    Report Number
    3006695864-2013-00209
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 22, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    LZS
    PMA / PMN Number
    P930016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM WAS EVALUATED BY AN AMO FIELD SERVICE ENGINEER AND NO ISSUES WERE FOUND THAT RELATE TO THE REPORTED EVENT. THE FIELD SERVICE ENGINEER FOUND A VERY SMALL WOBBLE IN THE BEAM BUT THE SYSTEM WAS WITHIN SPECIFICATION. CALIBRATIONS WERE PERFORMED TO OPTIMIZE ALL SETTINGS AND ALIGNMENTS. ALL PERTINENT INFORMATION AVAILABLE TO AMO HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THE CLINIC REPORTED THAT A LASER VISION CORRECTION PATIENT RECEIVED AN OVERCORRECTED TREATMENT IN EACH EYE. THE CLINIC INDICATED THAT THE PATIENT WAS OVER CORRECTED BY +0.5 AND +0.75 DIOPTER. AND THE PATIENT'S POST OP BEST CORRECTED VISUAL ACUITY WAS .7 AND .8 (20/30 & 20/25).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271197 STAR S4-IR-CE EXCIMER LASER EXCIMER LASER LZS ABBOTT MEDICAL OPTICS S4-IR-CE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other