BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELECTA II

    MDR report key: 2071951 · Received April 28, 2011

    Report

    Report Number
    1720381-2011-00022
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    May 24, 2011
    Report Date
    June 30, 2011
    Manufacturer
    LUMENIS, INC.
    Product Code
    GEX
    PMA / PMN Number
    K004006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CORRECTED MDR FILED WITH THIS SAME DATA SHOULD BE MDR 1720381-2011-00022 NOT -00014. A REVIEW OF CLINICAL NOTES OF (B)(6). BY A LUMENIS OPHTHALMOLOGIST AND (B)(6) CLINICAL EXPERT CONCLUDED THE FOLLOWING: THE PATIENT IS A (B)(6) FEMALE WITH JUVENILE OAG, LEFT EYE ALREADY ONLY WITH LP (LEGALLY BLIND), ELEVATED PRESSURE IN BOTH EYES ON MAXIMAL MEDICAL THERAPY (MMT). A 180 DEGREE SLT (NOT A FULL TREATMENT ACCORDING TO THE CONSENSUS PROTOCOL) WAS PERFORMED ON THE RIGHT EYE (THE ONLY FUNCTIONAL EYE) THAT RESULTED IN SLIGHT REDUCTION IN PRESSURE. DUE TO THE HIGH IOP IN A SINGLE EYE OF A YOUNG PATIENT SHE WAS REFERRED FOR SURGERY. REDUCTION OF 4MMHG WITH 180 SLT, IS WITHIN WHAT ONE WOULD EXPECT AT THIS VERY ADVANCED STAGE AND A VERY CONSERVATIVE TREATMENT (PERHAPS DUE TO INABILITY TO TREAT THE ENTIRE ANGLE). THE EXPERT CONCLUDED THAT THERE IS NO ADVERSE EVENT RELATED TO SLT EXCEPT THAT IT WAS NOT EFFECTIVE ENOUGH TO CONTROL THE IOP IN THIS PATIENT WITH A VERY PROGRESSIVE DISEASE. A REVIEW OF CLINICAL NOTES OF (B)(6) BY A LUMENIS OPHTHALMOLOGIST AND (B)(6) CLINICAL EXPERT CONCLUDED THE FOLLOWING: THE PATIENT IS A (B)(6) FEMALE WITH OCULAR HYPERTENSION WHO WAS TREATED WITH SLT IN HER RIGHT EYE. PROCEDURE FORMS SHOWS 180 DEGREE TREATMENT (POSSIBLY DUE TO PAS THAT DID NOT ENABLE A FULL 360 DEGREE TREATMENT) AND AN UNEVENTFUL PROCEDURE. PATIENT RECEIVED IOP LOWERING DROPS (APRACLONIDINE) BEFORE AND AFTER SLT WAS PERFORMED BUT NO ANTI-INFLAMMATORY DROPS. ONE DAY AFTER SLT, SOME MILD INFLAMMATION WAS NOTED, IOP WAS 22. PATIENT WAS STARTED ON DURAZOL (STEROID DROPS) AND ASKED TO CONTINUE THE IOP LOWERING DROPS. 4 DAYS POST SLT, IOP WAS 32. THE STEROIDS WERE STOPPED. THE FOLLOWING DAY THE PRESSURE WAS 50 AND THE IOP TREATMENT WAS ALSO CHANGED AND PATIENT WAS ENCOURAGED TO COMPLY WITH THE TREATMENT. 5 DAYS LATER, PRESSURE WAS DOWN TO 20 AND STABLE. ON LAST FOLLOW UP PRESSURE WAS 8. THE TREATING PHYSICIAN ALSO STIPULATED THAT THE PRESSURE SPIKE COULD HAVE BEEN DUE TO THE STEROID TREATMENT. AS THE PROCEDURE WAS UNEVENTFUL, ONLY 180 DEGREE OF THE ANGLE WAS TREATED, IT IS UNLIKELY THAT THE INFLAMMATORY REACTION WAS SO SEVERE THAT WOULD HAVE RESULTED IN SUCH A PRESSURE SPIKE AND THERE IS NO INDICATION OF SUCH A SEVERE REACTION IN THE CHARTS. NO DEVICE MALFUNCTION WAS SUSPECTED OR REPORTED TO HAVE BEEN THE CAUSATIVE FACTOR OF THESE EVENTS; THEREFORE, NO DEVICE EVALUATION OCCURRED.

    Additional Manufacturer Narrative · 1

    LUMENIS BECAME AWARE OF MULTIPLE ADVERSE EVENT REPORTS AFTER AN INTERNET USER GROUP DISCUSSION BEGAN REGARDING UNEXPECTED OUTCOMES TO SLT TREATMENT FOR GLAUCOMA. A REVIEW CONDUCTED BY LUMENIS CLINICAL GLAUCOMA EXPERTS CONCLUDED THE INCIDENCE RATE OF THESE REPORTS IS EXTREMELY LOW AND DO NOT AFFECT THE RISK LEVEL OF THE TREATMENT. REASONABLE ATTEMPTS WERE MADE BY TELEPHONE AND EMAIL TO OBTAIN FURTHER INFORMATION INCLUDING THE PATIENT'S VITAL HISTORY AND AGE, TREATMENT SETTINGS, REPORTED OUTCOME HOWEVER, NO FURTHER INFORMATION WAS PROVIDED IN ADDITION TO THE INFORMATION IN THE ORIGINAL REPORT. NO DEVICE MALFUNCTION WAS REPORTED; THEREFORE, NO DEVICE EXAMINATION OCCURRED. TO THE BEST KNOWLEDGE OF LUMENIS, THE DEVICE REMAINS IN USE AT THE USER FACILITY. A REVIEW OF DEVICE LABELING FOUND THAT RISKS TO TREATMENT ARE KNOWN AND OCCUR AT AN EXTREMELY LOW RATE OF TREATED POPULATION. A REVIEW BY A LUMENIS HEALTH PROFESSIONAL AND A GLAUCOMA SPECIALIST CONCLUDED THAT INSUFFICIENT INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TO DETERMINE A ROOT CAUSE. THE HEALTHCARE PROFESSIONALS ADDITIONALLY CONCLUDED THAT CLINICIANS ARE ADVISED TO TREAT PATIENTS WITH PIGMENTARY GLAUCOMA CONSERVATIVELY AS THESE PATIENTS ARE AT AN INCREASED RISK FOR ELEVATED IOP POST SLT. NO DEVICE MALFUNCTION REPORTED/SUSPECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO PATIENTS SUSTAINED ELEVATED INTRAOCULAR PRESSURE (IOP) AND A MILD INFLAMMATORY POST SELECTIVE LASER TRABECULOPLASTY (SLT) TO THE EYES FOR TREATMENT OF GLAUCOMA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO PATIENTS SUSTAINED ELEVATED INTRAOCULAR PRESSURE (IOP) POST SELECTIVE LASER TRABECULOPLASTY (SLT) TO THE EYES FOR TREATMENT OF GLAUCOMA. IT WAS FURTHER REPORTED THE PATIENTS WERE REFERRALS FROM ANOTHER CLINICIAN AND ONE PATIENT REQUIRED SURGERY AS MEDICAL INTERVENTION TO REDUCE THE ELEVATED IOP.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other