BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR

    MDR report key: 4592246 · Received March 11, 2015

    Report

    Report Number
    3006695864-2015-00069
    Event Type
    Injury
    Date Received
    March 11, 2015
    Date of Event
    December 20, 2014
    Report Date
    February 18, 2015
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    LZS
    PMA / PMN Number
    P930016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: IN INITIAL REPORT, THE INCORRECT PMA/510K WAS SELECTED. THIS FOLLOW UP HAS THE CORRECTION PMA AS IT IS P930016. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    (B)(4). FIELD SERVICE SPECIALIST (FSS) VISITED SITE TO CHECKOUT THE LASER SYSTEM DUE TO A USER REPORT OF UNDERCORRECTIONS. THE SYSTEM MET AMO SPECIFICATIONS UPON ARRIVAL. I WAS UNABLE TO CONFIRM THE REPORTED PROBLEM. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    ACCOUNT REPORTED PATIENT WAS UNDERCORRECTED AND PRESENTED WITH DIFFUSE LAMELLAR KERATITIS (DLK) IN LEFT EYE AND EPITHELIAL INGROWTH ONE DAY POST TREATMENT. ON (B)(6) 2014 1 DAY POST OP VISUAL ACUITY IN RIGHT EYE WAS 20/25 AND IN LEFT EYE WAS 20/100. ACCOUNT REPORTED ON (B)(6) 2015 THAT VISUAL ACUITY IN BOTH EYES WAS 20/200. MANIFEST REFRACTION IN RIGHT EYE -1.00 -0.75 X 107 20/20-1. MANIFEST REFRACTION IN LEFT EYE -1.00 -0.75 X 172 20/25. AN ENHANCEMENT WAS DONE ON (B)(6) 2015 WITH REMOVAL OF EPITHELIAL INGROWTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167511 STAR EXCIMER LASER LZS ABBOTT MEDICAL OPTICS 0030-1479

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention