BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR

    MDR report key: 4842751 · Received June 12, 2015

    Report

    Report Number
    3006695864-2015-00280
    Event Type
    Injury
    Date Received
    June 12, 2015
    Date of Event
    April 29, 2015
    Report Date
    August 27, 2015
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    LZS
    PMA / PMN Number
    P930016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS INCORRECTLY INDICATED IN THE INITIAL MDR THAT PATIENT BCVA READINGS FROM (B)(6) 2009 WAS A POST-OP READING WHEN IN FACT IT WAS A PRE-OP READING. PMA 510(K) - IN THE INITIAL REPORT THE INCORRECT NUMBER WAS PROVIDED. THE CORRECT NUMBER IS P930016. ADDITIONAL INFORMATION UDI #: (B)(4). EQUIPMENT LABELING PROVIDES POTENTIAL ADVERSE EFFECTS THAT CAN BE CAUSED BY THE SURGICAL/TREATMENT PROCEDURE BEING PERFORMED. THE OPERATOR MANUALS FOR THE VARIOUS EQUIPMENT WERE REVIEWED AND DETERMINED TO INCLUDE ADEQUATE WARNINGS FOR MEDICAL COMPLICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4)N THE CLINIC IS REPORTING THIS ADVERSE EVENT ONLY AND DID NOT REQUEST OR REQUIRE FIELD SERVICE OR CLINICAL SUPPORT. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED PLACEHOLDER .

    Description of Event or Problem · 1

    THE SURGERY CENTER REPORTED THAT A LASER VISION CORRECTION PATIENT EXPERIENCED ECTASIA ON BOTH (OU) AT 6+ YEAR POST OP EXAM. THE SURGERY CENTER¿S BRIEF DESCRIPTION IS THAT THE PATIENT CAME IN FOR A POSSIBLE ENHANCEMENT DUE TO DECREASE IN VISION; IT WAS THEN DETERMINE THE PATIENT HAD ECTASIA ON RIGHT EYE (OD) AND EARLY ECTASIA IN LEFT EYE (OS).THE PATIENT¿S CHIEF COMPLAINT WAS BLURRY VISION AND THAT THE PATIENT WAS A FIRE FIGHTER THAT HAD FAILED THE VISION SCREENING. THE DATE OF DISCOVERY OF ECTASIA WAS ON (B)(6) 2015 AND THE TREATMENT WAS ON (B)(6) 2009. BCVA FROM (B)(6) 2009: RIGHT EYE POST-OP 20/20 -.1.50 X -2.25 X 165, LEFT EYE POST-OP 20/20 -1.50 X -2.75 X 8. BCVA FROM (B)(6) 2015: RIGHT EYE POST-OP 20/20 1.25 X -4.00 X 45, LEFT EYE POST-OP 20/20 1.00 X -1.00 X 116.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384297 STAR EXCIMER LASER LZS ABBOTT MEDICAL OPTICS 0030-2450

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other