BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 3863957 · Received June 10, 2014

    Report

    Report Number
    3006695864-2014-00297
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 16, 2014
    Report Date
    March 19, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL MDR CONTAINS AN INCOMPLETE STATEMENT, IT READS: PRE-OP BCVA WAS IN BOTH EYES. THE CORRECT STATEMENT SHOULD READ: PRE-OP BCVA WAS 20/20 IN BOTH EYES. CONCOMITANT PRODUCT - ADDED WAVELIGHT (B)(4). PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EQUIPMENT WAS NOT EVALUATED AFTER THE TREATMENT BECAUSE THERE WAS NO INDICATION THAT A MALFUNCTION CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THE CLINIC IS REPORTING THIS EVENT ONLY AND DID NOT REQUEST FIELD SERVICE OR CLINICAL SUPPORT. AN AMO REPRESENTATIVE VISITED THE SITE ON (B)(4) 2014 FOR A NORMALLY SCHEDULED PREVENTIVE MAINTENANCE AND DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE EVENT. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED STINGING ON PATIENT'S LEFT EYE. LEFT EYE STARTED STINGING AFTER INSTILLATION OF LOTEMAX (PRESCRIBED A MONTH PRIOR FOR TRANSIENT LIGHT SENSITIVITY (TLS) ON BOTH EYES STATUS POST LASIK). AN ORAL STEROID WAS NOT PRESCRIBED. TOPICAL STEROID DOSAGE WAS NOT INCREASED. A FLAP LIFT AND RINSE WAS NOT PERFORMED. PATIENT HAD DRY EYE. PATIENT DID NOT EXPERIENCE A LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA). PRE-OP BCVA WAS ON BOTH EYES. PATIENT DISCARDED THE DROPS THINKING SHE CONTAMINATED THE TIP. PATIENT ADVISED TO USE PRESERVATIVE FREE TEARS AND STOP LOTEMAX. CONDITIONS WERE REPORTED AS RESOLVING. CUSTOMER REPORTED THAT THE TLS WAS WORSENING ON BOTH EYES. TOPICAL STEROID DOSAGE WAS INCREASED. PATIENT REPORTED THAT SHE HAS TO WEAR TWO PAIRS OF SUNGLASSES OUTSIDE. CUSTOMER REPORTED THAT THE DRY EYE AND STINGING HAVE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339038 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20005D

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other WAVELIGHT (B)(4)