BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIPIFLOW THERMAL PULSATION SYSTEM

    MDR report key: 2394901 · Received November 30, 2011

    Report

    Report Number
    3008169506-2011-00001
    Event Type
    Injury
    Date Received
    November 30, 2011
    Date of Event
    October 22, 2011
    Report Date
    November 30, 2011
    Manufacturer
    TEARSCIENCE
    Product Code
    ORZ
    PMA / PMN Number
    K093937
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDICAL RECORDS WERE PROVIDED. THE ONLY INFORMATION PROVIDED WAS THROUGH CONVERSATION WITH TREATING PHYSICIAN, WHO REPORTED THAT THE DEVICE DID NOT CAUSE THE EVENT (CORNEAL ABRASION) BECAUSE THE PATIENT'S EYE WAS UNAFFECTED IMMEDIATELY AFTER TREATMENT AND AT TWO DAYS AFTER TREATMENT. THEREFORE, THE DETAILS OF THE PATIENT'S HISTORY, INCLUDING EVENT OCCURRENCE AND SEVERITY, OTHER FACTORS THAT MAY HAVE CONTRIBUTED TO THE EVENT, AND ANY OTHER RELATED INFORMATION ABOUT THE PATIENT ARE UNKNOWN BECAUSE THE MEDICAL RECORDS WERE NOT AVAILABLE. THIS EVENT IS BEING REPORTED AS A CORNEAL ABRASION, WORST CASE, WHICH MAY OR MAY NOT MEET THE DEFINITION OF SERIOUS INJURY. SINCE THE SEVERITY OF THE EVENT IS UNKNOWN AND SINCE THE PATIENT WAS REPORTEDLY TREATED WITH AN ANTIBIOTIC PROPHYLACTICALLY TO PREVENT INFECTION, THIS EVENT IS BEING REPORTED CONSERVATIVELY AS A SERIOUS INJURY, EVEN THOUGH THERE WAS NO PERMANENT IMPAIRMENT TO THE PATIENT. IN ADDITION, IT IS EXTREMELY UNLIKELY THAT THE DEVICE CAUSED A CORNEAL ABRASION BECAUSE THERE WAS NO ABRASION OR ANY ADVERSE EFFECT PRESENT IMMEDIATELY AFTER TREATMENT OR WITHIN TWO DAYS AFTER TREATMENT. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. THE DEVICE HISTORY RECORD AND RETAINED SAMPLES WERE EVALUATED AND MET SPECS. HOWEVER, SINCE THE EVENT OCCURRED WITHIN ONE WEEK AFTER TREATMENT, THIS EVENT IS BEING REPORTED CONSERVATIVELY BECAUSE WE CANNOT RULE OUT THE POSSIBILITY THAT THE DEVICE TREATMENT CONTRIBUTED TO THE EVENT. IT IS MOST LIKELY THAT THE CORNEAL ABRASION WAS A DIRECT RESULT OF THE PATIENT'S PRE-EXISTING CONDITION, EYE PAIN IN THE LEFT EYE, RECURRENT CORNEAL EROSION AND SEVERE KERATOPATHY IN BOTH EYES, WHICH MAKES THE PATIENT PREDISPOSED TO CHRONIC AND REPEATED CORNEAL STAINING AND ABRASION. IN ADDITION, AN OCULAR SURFACE ABNORMALITY THAT MAY COMPROMISE CORNEAL INTEGRITY, SUCH AS RECURRENT CORNEAL EROSION, IS A LABELED CONTRAINDICATION OF THE DEVICE TREATMENT IN THE INSTRUCTIONS FOR USE. ADDITIONAL MODEL NUMBER: LFD-1000.

    Description of Event or Problem · 1

    PATIENT HAD A PRE-EXISTING HISTORY OF SEVERE DRY EYE SYMPTOMS WITH SEVERE KERATOPATHY, LAGOPHTHALMOS, CORNEAL SCARRING, RECURRENT CORNEAL EROSION AND MEIBOMIAN GLAND DYSFUNCTION. THE PATIENT ALSO HAD A PRIOR HISTORY OF EYE PAIN IN THE LEFT EYE. PRIOR TO TREATMENT, THE PATIENT HAD AN INFERIOR BAND OF PUNCTATE CORNEAL STAINING AND CORNEAL SCARS NOTED. AFTER TREATMENT ON THE SAME DAY, THE PATIENT'S CORNEA WAS UNCHANGED ON SLIT LAMP EVALUATION. AT A SCHEDULED APPOINTMENT TWO DAYS AFTER TREATMENT, THE CORNEA WAS THE SAME AS BEFORE (UNCHANGED FROM PRIOR TO TREATMENT). THE PATIENT RETURNED FOUR DAYS AFTER TREATMENT AND AN INCREASE IN CORNEAL PUNCTATE STAINING IN THE LEFT EYE WAS OBSERVED. THE PATIENT WAS SEEN AT THE EMERGENCY ROOM COMPLAINING OF PAIN IN THE LEFT EYE FIVE DAYS FOLLOWING TREATMENT. A CORNEAL ABRASION WAS NOTED IN THE MEDICAL RECORD AND THE PATIENT WAS TREATED WITH A TOPICAL ANTIBIOTIC AND OINTMENT. A WEEK AND A HALF LATER, THE PATIENT RETURNED TO THE TREATMENT PHYSICIAN; MILD CORNEAL STAINING WAS OBSERVED IN THE LEFT EYE BUT THERE WAS NO CORNEAL ABRASION. THE LEFT EYE HAD HEALED WITH NO PERMANENT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIPIFLOW THERMAL PULSATION SYSTEM ORZ TEARSCIENCE LFH-1000 110725

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention