BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELECTA II 110V

    MDR report key: 3738561 · Received April 10, 2014

    Report

    Report Number
    1720381-2014-00022
    Event Type
    Injury
    Date Received
    April 10, 2014
    Date of Event
    August 15, 2013
    Report Date
    April 9, 2014
    Manufacturer
    LUMENIS, INC.
    Product Code
    GEX
    PMA / PMN Number
    K004006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LUMENIS INVESTIGATED THE EVENT REPORT CONTACTING THE USER FACILITY TO REQUEST PATIENT TREATMENT RECORDS AND OTHER RELEVANT EVENT INFORMATION. THE PATIENT'S CLINICAL RECORD WAS PROVIDED TO LUMENIS FOR REVIEW. AN EXAMINATION OF THE SUBJECT DEVICE BY A LUMENIS TECHNICAL EXPERT CONCLUDED THE SYSTEM PERFORMED TO REQUIRED MANUFACTURER SPECIFICATIONS. NO RELATED DEVICE MALFUNCTION WAS OBSERVED. SUBJECT DEVICE MALFUNCTION IS NOT THE SUSPECTED CAUSE OF THE REPORTED EVENT. A LUMENIS MEDICAL DIRECTOR REVIEWED THE PATIENT'S TREATMENT RECORD CONCLUDING, CORNEAL EDEMA POST SLT IS A HIGHLY RARE OCCURRENCE (~0.8%). ALTHOUGH CERTAIN CAUSES ARE POSTULATED TO PLAY A ROLE IN THIS COMPLICATION, IT IS NOT YET UNDERSTOOD WHAT MAY PREDISPOSE A PATIENT TO CORNEAL CHANGES AS A RESULT OF SLT. THERE HAVE BEEN ONLY VERY FEW REPORTED CASES IN LITERATURE; AND VIRTUALLY ALL THE CASES REPORTED RESOLVED WITH STEROID. ONE COMMONALITY IS THAT MOST OF THESE CASES WERE TREATED AT HIGH ENERGY AND WITH 100 SPOTS OR GREATER. THIS COULD HAVE BEEN AN ABNORMAL CYTOKINE REACTION OR ABSORPTION BY THE ENDOTHELIUM (IF THERE IS DRIFTING PIGMENT, SUCH IN CASES OF PGS OR PXF) OR THE PHYSICIAN MAY HAVE ERRED AND TREATED SAMPOLESI'S LINE INSTEAD OF THE TM - RESULTING IN AN ENDOTHELIALITIS.

    Additional Manufacturer Narrative · 1

    DURING A FOLLOW-UP DISCUSSION BETWEEN A LUMENIS CLINICAL EXPERT AND THE TREATING PHYSICIAN THE CLINICAL EXPERT CONCLUDED, "THIS APPEARS TO BE AN ADVERSE EVENT RELATED TO HIGH ENERGY UPTAKE IN EXCESSIVELY PIGMENTED TRABECULAR MESHWORK. GIVEN THE SELECTED TREATMENT PARAMETERS OF 0.8 MJ (COMPARED TO OUR RECOMMENDED 0.4 MJ IN CASE OF PIGMENTARY GLAUCOMA OR EXCESSIVELY PIGMENTED TRABECULAR MESHWORK) AND THE TREATED AREA (INFERIOR, INSTEAD OF SUPERIOR ANGLE - IN CASE OF PIGMENTARY GLAUCOMA, DUE TO PIGMENT DEPOSITION PATTERNS), A CORNEAL HAZE DEVELOPED, WHICH IS CONSISTENT WITH OTHER RARE REPORTS (~0.8%) IN MEDICAL LITERATURE. IT IS NOTEWORTHY THAT THE AREA OF THE HAZE APPEARS TO BE LOCALIZED TO THE AREA OF THE CONTACT GONIO-LENS USED IN THE PROCEDURE. THE PHYSICIAN CONFIRMED THAT NO CHEMICALS WERE USED IN CLEANING THE LATINA SLT LENS, WHICH COULD HAVE CONTRIBUTED TO THE LOCALIZATION EFFECT. THE PHYSICIAN SUGGESTED CORRECTLY TO ADAPT THEIR SLT TREATMENT PROTOCOL TO CONFORM WITH THE LUMENIS RECOMMENDATIONS, IN ORDER TO POTENTIALLY AVOID RECURRENCE OF SUCH INCIDENCES IN THE FUTURE."

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT A PATIENT SUSTAINED CORNEAL EDEMA OF THE RIGHT EYE POST SLT. THE REPORTING PHYSICIAN STATED PATIENT'S VISUAL ACUITY DECREASED FROM 20/20 TO 20/80 THREE DAYS FOLLOWING THE PROCEDURE. THE PHYSICIAN REPORTED PRESCRIBING LONG TERM STEROID DROPS (PRED FORTE) AS MEDICAL INTERVENTION STATING THE PATIENT HAS EXPERIENCED VERY GRADUAL VISUAL IMPROVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218254 SELECTA II 110V ND:YAG PHOTOCOAGULATOR GEX LUMENIS, INC. SELECTA II 110V

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other