BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR

    MDR report key: 5352577 · Received January 7, 2016

    Report

    Report Number
    3006695864-2016-00028
    Event Type
    Injury
    Date Received
    January 7, 2016
    Date of Event
    October 22, 2015
    Report Date
    January 7, 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

    (B)(4). FIELD SERVICE SPECIALIST VISITED ACCOUNT AFTER THE EVENT DURING A ROUTINE SYSTEM CHECK AND UPS WAS REPLACED. OBSERVED TORN PILLOW AND REPLACED. PERFORMED PERFORMANCE TASKLIST AND SYSTEM MET AMO SPECIFICAITONS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT HAD A PHOTOREFRACTIVE KERATECTOMY PROCEDURE IN BOTH EYES ON (B)(6) 2015. VISUAL ACUITY PRIOR TO SURGERY WAS 20/25 IN BOTH EYES (GLASSES) AND MANIFEST REFRACTION (MR) WAS -8.50 SHP IN RIGHT EYE AND -8.75 X -0.50 X 160 IN LEFT EYE. UNCORRECTED VISUAL ACUITY POST OP AS FOLLOWS: 1 DAY RIGHT EYE 20/60 AND LEFT EYE 20/400; 1 WEEK RIGHT EYE 20/60 AND LEFT EYE 20/50; 1 MONTH RIGHT EYE 20/40-2 AND LEFT EYE 20/40-1; 1 MONTH MR +1.50 X -0.50 X 13 WITH BEST CORRECTED VISUAL ACUITY (BCVA) RIGHT EYE 20/25-2 AND LEFT EYE +0.50 X -0.50 X 45 BCVA 20/30. 2 MONTHS RIGHT EYE +1.25 X -0.25 X 30 BCVA 20/25 AND LEFT EYE +0.25 X -0.50 X 49 BCVA 20/25-2 IT WAS REPORTED THAT PATIENT HAD PHOTOTHERAPEUTIC KERATECTOMY ENHANCEMENT ON (B)(6) 2015 AND DEVELOPED CENTRAL ISLAND POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9268 STAR EXCIMER LASER LZS ABBOTT MEDICAL OPTICS 0030-1479

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other