Cyclo G6 Laser Console 66245-1Recalls & reported problems
Iridex Corporation · Class 2
All models of Cyclo G6 Laser Console (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 14
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00813125016555), received between Sep 21, 2018 and Oct 21, 2021 — classified as 14 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem7
- Insufficient Device Problem Information4
- Appropriate Device Problem Term/Code Not Available1
- Improper or Incorrect Procedure or Method1
- Positioning Problem1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
- Blurred Vision2
- Eye Burn2
- Visual Impairment2
- Cardiac Arrest1
- Heart Failure1
- Insufficient Information1
- Intraocular Pressure Decreased1
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
InjuryOct 21, 2021Adverse Event Without Identified Device or Use Problem
IRIDEX BECAME AWARE OF A COMPLAINT REPORTING A CASE OF MYDRIASIS FOLLOWED BY BLURRY VISION POST TREATMENT USING A CYCLO G6 CONSOLE WITH A MICROPULSE P3 PROBE. MYDRIASIS IS A CONDITION WHERE THE PUPIL OF THE EYE IS FIXED AND DILATED. THE DOCTOR WAS A NEW IRIDEX DEVICE USER. THE PROCEDURE WAS INTENDED BY AN IRIDEX REPRESENTATIVE WHO CONFIRMED THAT TREATMENT SETTINGS WERE WITHIN SPECIFICATION AND THE DOCTOR USED A GOOD TECHNIQUE. THIS COMPLAINT DID NOT INVOLVE ANY REPORT OF MALFUNCTION OF THE LASER CONSOLE AND PROBE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED.
Patient problems: Blurred Vision
MAUDE report 12677653 ↗InjuryOct 21, 2021Positioning Problem
IRIDEX BECAME AWARE OF A COMPLAINT REPORTING A CASE OF MYDRIASIS FOLLOWED BY BLURRY VISION POST TREATMENT USING A CYCLO G6 CONSOLE WITH A MICROPULSE P3 PROBE. MYDRIASIS IS A CONDITION WHERE THE PUPIL OF THE EYE IS FIXED AND DILATED. THE DOCTOR WAS A NEW IRIDEX DEVICE USER. THE PROCEDURE WAS INTENDED BY AN IRIDEX REPRESENTATIVE WHO CONFIRMED THAT TREATMENT SETTINGS WERE WITHIN SPECIFICATION AND THE DOCTOR USED A GOOD TECHNIQUE. IN THIS CASE THE PATIENT WAS HIGHLY MYOPIC. IN CASES WHERE THE PATIENT IS HIGHLY MYOPIC IT CAN BE DIFFICULT TO DISTINGUISH THE REGION OF THE LIMBUS. THIS MAY RESULT IN THE PROBE BEING POSITIONED INCORRECTLY (E.G. POSITIONED TOO ANTERIOR). IF TREATMENT WAS PERFORMED IN THE INCORRECT LOCATION, THIS COULD BE A CONTRIBUTING FACTOR TO THE OBSERVED RESULT. THIS COMPLAINT DID NOT INVOLVE ANY REPORT OF MALFUNCTION OF THE LASER CONSOLE AND PROBE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision
MAUDE report 12677628 ↗InjuryAug 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IRDEX BECAME AWARE OF AN ADVERSE EVENTS FROM LITERATURE REVIEW INVOLVING CASES OF HYPHEMA,CHOROIDAL EFFUSION AND PERSISTENT MYDRIASIS. A STUDY WAS CONDUCTED IN 95 PATIENTS TO EVALUATE THE SAFETY AND EFFECTIVENESS OF DOUBLE-SESSION MICROPULSE TRANSSCLERAL LASER (MP3) AS A PRIMARY TREATMENT MODALITY FOR GLAUCOMA. THE ARTICLE MENTIONS THAT ALL PATIENTS HAD SIGNIFICANT INTRAOCULAR PRESSURE-LOWERING COMPARED TO BASELINE AND THE SUCCESS WAS ACHIEVED WITH ONE TREATMENT IN 76.8% PATIENTS. NO SPECIFIC FOLLOWUP DETAILS OR PATIENT INFORMATION WAS AVAILABLE IN RELATIONSHIP TO THE PATIENTS WHO EXPERIENCED THE ADVERSE EVENTS. THE ARTICLE CONCLUDES THAT MICROPULSE TRANSSCLERAL CYCLOPHOTOCOAGULATION IS A SAFE AND EFFICACIOUS TREATMENT FOR GLAUCOMA. NO DEVICES WERE RETURNED TO IRIDEX SO ENGINEERING FAILURE ANALYSIS COULD NOT BE PERFORMED. A DEFINITIVE ROOT CAUSE FOR THE ADVERSE EVENTS COULD NOT BE DETERMINED BASED ON THE INFORMATION PROVIDED. THE IRIDEX BIOMEDICAL ENGINEER COMPLETED A REVIEW OF COMPLAINT HISTORY TO IDENTIFY AND REVIEW SIMILAR EVENTS. BASED ON THE RESULTS OF REVIEW, IT DOES NOT APPEAR THAT THESE EVENTS ARE OCCURING WITH AN INCREASED FREQUENCY OR SEVERITY. LITERATURE REFERENCE: EARLY
Patient problems: Insufficient Information
MAUDE report 12264054 ↗InjuryAug 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IRIDEX BECAME AWARE OF AN ADVERSE EVENT FROM LITERATURE REVIEW. A STUDY WAS CONDUCTED TO INVESTIGATE THE CLINICAL EFFICACY AND SAFETY PROFILE OF MICROPULSE TRANSSCLERAL CYCLOPHOTOCOAGULATION (MP-CPC) IN PATIENTS WITH REFRACTORY GLAUCOMA. THE STUDY NOTED 2 PATIENTS WITH PHTHISIS,7 PATIENTS WITH HYPOTONY AND 13 PATIENT WITH LOSS OF VISUAL ACUITY AFTER MICROPULSE TRANSSCLERAL CYCLOPHOTOCOAGULATION. THE STUDY CONCLUDED THAT MP-CPC IS AN EFFECTIVE TREATMENT FOR PATIENTS WITH REFRACTORY GLAUCOMA AND THAT SHORTER TREATMENT TIMES WITH MORE FREQUENT REPEAT TREATMENTS MAY BE CONSIDERED GIVEN THE INCIDENCE OF SIGNIFICANT VISION LOSS IN THIS STUDY. NO PATIENT FOLLOWUP INFORMATION HAS BEEN PROVIDED IN THE ARTICLE. LITERATURE REFERENCE: "CLINICAL EFFICACY AND SAFETY PROFILE OF MICROPULSE TRANSSCLERAL CYCLOPHOTOCOAGULATION IN REFRACTORY GLAUCOMA - PUBMED." PUBMED, HTTPS://PUBMED.NCBI.NLM.NIH.GOV/29521718/.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Visual Impairment
MAUDE report 12264051 ↗InjuryAug 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IRIDEX BECAME AWARE OF AN ADVERSE EVENT FROM LITERATURE REVIEW. A STUDY WAS CONDUCTED TO COMPARE THE SAFETY AND EFFICACY OF MICROPULSE CYCLOPHOTOCOAGULATION (MP-CPC) AND TRANSSCLERAL CONTINUOUS WAVE CYCLOPHOTOCOAGULATION (CW-CPC) FOR THE TREATMENT OF REFRACTORY GLAUCOMA. THE ARTICLE DISCUSSES ONE CASE OF HYPOTONY THAT DEVELOPED INTO PHTHISIS BULBI FOLLOWING CW-CPC TREATMENT. NO ADDITIONAL PATIENT INFORMATION IS AVAILABLE. THE FINAL CONLUSION OF THE ARTICLE NOTED THAT BOTH MP-CPC AND CW-CPC PROVIDE A SAFE AND EFFECTIVE TREATMENT METHOD FOR IN LOWERING THE IOP IN PATIENTS WITH REFRACTORY GLAUCOMA. A REVIEW OF COMPLAINT HISTORY WAS COMPLETED. BASED ON THE RESULTS OF THIS REVIEW, THIS EVENT DOES NOT APPEAR TO BE A PART OF AN INCREASING TREND. BECAUSE THIS ADVERSE EVENT WAS IDENTIFIED THROUGH LITERATURE REVIEW, THERE WERE NO DEVICES RETURNED FOR ENGINEERING FAILURE ANALYSIS. A DEFINITIVE ROOT CAUSE FOR THE EVENT COULD NOT BE DETERMINED. LITERATURE REFERENCE: MICROPULSE CYCLOPHOTOCOAGULATION: A MULTICENTER STUDY OF EFFICACY, SAFETY, AND FACTORS ASSOCIATED WITH INCREASED RISK OF COMPLICATIONS - PUBMED." PUBMED, HTTPS://PUBMED.NCBI.NLM.NIH.GOV/32852377/.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12264027 ↗InjuryAug 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IRIDEX BECAME AWARE OF AN ADVERSE EVENT FROM LITERATURE REVIEW. A STUDY WAS CONDUCTED TO EVALUATE THE SAFETY AND EFFECTIVENESS OF THE MICROPULSE CYCLOPHOTOCOAGULATION ON 167 EYES WITH VARIOUS TYPES AND STAGES OF GLAUCOMA. THE ARTICLE STATES THAT THE PROCEDURE LOWERED IOP IN THE SHORT TERM, SIXTY-THREE PERCENT OF THE PATIENTS REQUIRED ADDITIONAL IOP LOWERING INTERVENTION. FORTY-SEVEN PERCENT OF THE PATIENTS REQUIRED ADDITIONAL IOP LOWERING INTERVENTION. MYDRIASIS HAD NOT RESOLVED IN NEARLY TWO THIRDS WHO DEVELOPED THIS COMPLICATION. THIS STUDY SPECIFICALLY NOTED TWO CASES OF PERSISTENT MYDRIASIS FOLLOWING TREATMENT. IRIDEX PREVIOUSLY BECAME AWARE OF THESE TWO INSTANCES THROUGH DIRECT REPORT FROM THE PHYSICIAN. THESE ADVERSE EVENTS WERE REPORTED. ENGINEERING FAILURE ANALYSIS COULD NOT BE PERFORMED BECAUSE NO DEVICES WERE RETURNED TO IRIDEX. RESULTS OF COMPLAINT HISTORY REVIEW INDICATE THAT THIS ISSUE IS NOT OCCURRING WITH AN INCREASED FREQUENCY OR SEVERITY. LITERATURE REFERENCE: "MICROPULSE CYCLOPHOTOCOAGULATION: A MULTICENTER STUDY OF EFFICACY, SAFETY, AND FACTORS ASSOCIATED WITH INCREASED RISK OF COMPLICATIONS - PUBMED." PUBMED, HTTPS://PUBMED.NCBI.NLM.NIH.GOV/32852377/.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Intraocular Pressure Decreased
MAUDE report 12264025 ↗InjuryJul 1, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
PART A IS NOT FILLED OUT AS PATIENT IDENTIFIER DETAILS WERE NOT PROVIDE TO IRIDEX. THIS REPORT HAS BEEN CREATED TO MAKE CORRECTIONS TO THE PREVIOUS REPORT. THE CHANGES INCLUDE: 1) REPORT C: IS THIS A COMBINATION PRODUCT - NO. 2) PART H: UPDATE TO INCLUDE THAT THIS A CORRECTION REPORT. 3) PART D: UPDATED THIS SECTION WITH THE UDI NUMBER. 4) PART E: UPDATES TO THE INITIAL REPORTER SECTION WITH INFORMATION REGARDING THE COMPLAINANT . THE FOLLOWING TEXT WERE PROVIDED IN THE INITIAL REPORT: IRIDEX BECAME AWARE OF A COMPLAINT REPORTING A PATIENT EXPERIENCING CONJUNCTIVAL BURN DURING TREATMENT WITH THE MICROPULSE P3 PROBE. THE COMPLAINT ALSO REPORTS THE PRESENCE OF MUCUS ON THE PROBE TIP DURING TREATMENT. BASED ON THE INFORMATION PROVIDED BY THE DOCTOR THE MOSTLY LIKELY REASON WAS DETERMINED TO BE USE OF THE DEVICE AFTER THE DEVICE TIP WAS CONTAMINATED. PAGE 1 OF THE MICROPULSE P3 IFU CONTAINS INSTRUCTIONS FOR INSPECTING AND CLEANING THE DEVICE TIP DURING USE. PAGE 1 OF THE IFU CONTAINS 'CONTAMINATION OF THE DEVICE TIP WITH BLOOD OR TISSUE OF THE FIBER OPTIC BY BLOOD OR TISSUE CHAR CAN RESULT IN SURFACE BURNS IN THE EYE'. ENGINEERING FAILURE ANALYSIS COULD NOT BE PERFORMED BECAUSE THE DEV
Patient problems: Eye Burn
MAUDE report 12100888 ↗InjuryNov 5, 2020Adverse Event Without Identified Device or Use Problem
IRIDEX BECAME AWARE OF THE COMPLAINT INVOLVING PATIENT EXPERIENCING CARDIAC ARREST FOLLOWING A TRANSCLERAL LASER THERAPY TREATMENT USING CYCLO G6 WITH A MICROPULSE P3 PROBE. THE PATIENT WAS GIVEN GENERAL ANAESTHESIA VERSUS THE LOCAL PERIBULBER OR RETROBULBAR ANAESTHESIA AS SUGGESTED IN THE PRODUCT INDICATIONS FOR USE. THE MOST LIKELY CAUSE FOR THIS EVENT IS SUSPECTED TO BE THE COMBINATION OF GENERAL ANAESTHETIC AND UNDERLYING PATIENT HEALTH CONDITIONS. THE LASER THERAPY IS NOT BELIEVED TO HAVE CAUSED OR CONTRIBUTED TO THIS EVENT. HOWEVER A DEFINITIVE CONCLUSION ON CAUSE COULD NOT BE DETERMINED. THE PATIENT WAS TREATED AND RECOVERED. FAILURE ANALYSIS WAS PERFORMED ON THE RETURNED DEVICE. NO MALFUNCTIONS OR ERRORS WERE OBSERVED. THE RESULTS INDICATE THE SYSTEM IS FUNCTIONING WITHIN SPECIFICATIONS.
Patient problems: Heart Failure
MAUDE report 10793425 ↗InjuryNov 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IRIDEX BECAME AWARE OF A COMPLAINT INVOLVING A POTENTIAL CONJUNCTIVAL BURN AFTER A TRANSCLERAL PHOTOCOAGULATION PROCEDURE USING A MICROPULSE P3 DEVICE. THE DOCTOR REPORTED OBSERVING SMOKE COMING FROM THE TIP OF THE DEVICE AT THE BEGINNING OF TREATMENT. THE DOCTOR ABORTED THE PROCEDURE AFTER THIS OBSERVATION. A CONJUNCTIVAL BURN WAS SUSPECTED, HOWEVER THIS WAS NOT CONFIRMED. THE IFU FOR THE MICROPULSE P3 PROBE PROVIDES INSTRUCTIONS TO THE USER TO ABORT THE PROCEDURE IF SMOKE IF ABSORBED. THE USER FOLLOWED THE INSTRUCTIONS IN THIS CASE. THE MOST LIKELY CAUSE IS THAT THE LASER WAS ACTIVATED OVER BLOOD OR BETADINE DURING THE INITIAL TREATMENT. THESE PIGMENTED RECEPTORS CAN ABSORB ENERGY AND CAUSE HEAT BUILD-UP THAT COULD CAUSE AN INJURY IN THE FORM OF A BURN. THE IFU ALSO PROVIDES INSTRUCTIONS TO THE USER TO EXAMINE THE TIP OF THE DEVICE TO MAKE SURE NO BLOOD OR OTHER CONTAMINANTS ARE PRESENT. PER THE IFU 'EXCESSIVE TREATMENT POWER MAY RESULT IN OCULAR SURFACE BURNS OR CILIARY BODY HEMORRHAGE. CONTAMINATION OF THE FIBER OPTIC TIP BY BLOOD OR TISSUE CHAR MAY RESULT IN OCULAR SURFACE BURNS. EXCESSIVE ENERGY MAY CAUSE EQUATORIAL BURNS. HEAVY PERILIMBAL CONJUNCTIVAL PIGMENTATION MAY RESULT
Patient problems: Eye Burn
MAUDE report 10793402 ↗InjuryNov 5, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IRIDEX BECAME AWARE OF A COMPLAINT INVOLVING A PATIENT EXPERIENCING CARDIAC ARREST FOLLOWING A TRANSSCLERAL CYCLOPHOTOCOAGULATION PROCEDURE USING A CYCLO G6 LASER CONSOLE WITH A MICROPULSE P3 PROBE. THE PHYSICIAN COMMUNICATED TO THE IRIDEX REPRESENTATIVE THAT THE PATIENT RECOVERED AND WAS DISCHARGED. THE MOST LIKELY CAUSE FOR THIS EVENT IS SUSPECTED TO BE ADVERSE REACTION TO GENERAL ANESTHESIA POTENTIALLY IN COMBINATION WITH PATIENT'S HEALTH CONDITIONS. THE LASER THERAPY IS NOT BELIEVED TO HAVE CAUSED OR CONTRIBUTED TO THIS EVENT. HOWEVER, A DEFINITIVE CONCLUSION ON CAUSE COULD NOT BE DETERMINED. NO FAILURE ANALYSIS WAS PERFORMED ON THE DEVICE AS IT WAS NOT RETURNED TO IRIDEX. NO MALFUNCTIONS OR ERRORS WERE OBSERVED DURING TREATMENT. A REVIEW OF COMPLAINT HISTORY FROM JANUARY 2017 TO CURRENT WAS COMPLETED AND ONE SIMILAR INCIDENT WAS IDENTIFIED. DURING THIS PERIOD OVER 108,000 PROCEDURES WERE COMPLETED WITH CYCLO G6 USING MP3 PROBE. THE IFU FOR THE MICROPULSE P3 PROBE REFERENCES USE OF LOCAL ANESTHESIA. IN THE IFU UNDER THE ANESTHESIA SECTION "TYPICALLY AN ANESTHESIA BLOCK IS USED DURING THESE PROCEDURES". ATTEMPTS TO CONTACT THE PHYSICIAN FOR ADDITIONAL INFORMATION BY PHONE, VOICE
Patient problems: Cardiac Arrest
MAUDE report 10793227 ↗InjuryJan 10, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
IRIDEX RECEIVED A REPORT OF A PATIENT INJURY INVOLVING A SCLERAL BURN. THE BURN OCCURRED DURING A TREATMENT WITH THE G-PROBE ILLUMINATE DEVICE IN CONJUNCTION WITH A CYCLO G6 LASER CONSOLE.
Patient problems: Radiation Burn
MAUDE report 9578474 ↗InjuryDec 5, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IRIDEX RECEIVED A COMPLAINT REPORTING THAT A PATIENT EXPERIENCED A LOSS OF OCULAR PRESSURE AND VISUAL ACUITY FOLLOWING TRANSSCLERAL CYCLOPHOTOCOAGULATION TREATMENT. THIS INCIDENT APPEARS TO BE RELATED TO OVERTREATMENT RESULTING FROM THE PHYSICIAN USING TREATMENT SETTINGS ABOVE THE RECOMMENDATIONS IN THE INSTRUCTIONS FOR USE (2500MW FOR 80 SECONDS PER HEMISPHERE DELIVERING A TOTAL ENERGY OF 125.2 JOULES VS. THE RECOMMENDED 2000MW FOR 80 SECONDS PER HEMISPHERE DELIVERING 100.16 JOULES OF TOTAL ENERGY). THAT PATIENT'S VISUAL ACUITY AND OCULAR PRESSURE RECOVERED FOLLOWING POST-OPERATIVE TREATMENT WITH STEROIDS. THAT PATIENT'S VISUAL ACUITY AND OCULAR PRESSURE RECOVERED FOLLOWING POST-OPERATIVE TREATMENT WITH STEROIDS.
Patient problems: No Code Available
MAUDE report 9419813 ↗InjuryFeb 14, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IRIDEX RECEIVED A REPORT OF SCLERAL LACERATION FOLLOWING USE OF A MICROPULSE (MP3) PROBE WITH THE CYCLO G6 LASER CONSOLE. THE PHYSICIAN REPORTED THAT THE LACERATION APPEARED TO REACH ALMOST ALL LAYERS OF THE SCLERA. THE PATIENT IN THIS CASE WAS UNDERGOING A SECOND MICROPULSE TRANSSCLERAL CYCLOPHOTOCOAGULATION TREATMENT (MP-TSCPS) FOLLOWING INITIAL TREATMENT THREE MONTHS PRIOR. THE LASER SETTINGS WERE WITHIN THE RECOMMENDED SETTINGS, 2000MW AND THE PHYSICIAN INDICATED THAT THE UPPER AND LOWER HEMISPHERE OF THE LEFT EYE WERE RECIPROCATED TWICE FOR 20 SECONDS IN EACH DIRECTION. THE PHYSICIAN REPORTED THAT THE PATIENT WAS EXPERIENCING SIGNIFICANT SUBCONJUNCTIVAL BLEEDING AT THE ANESTHESIA INJECTION SITE PRIOR TO RECEIVING TREATMENT. THE PHYSICIAN PERFORMED THE TREATMENT AND DISCHARGED THE PATIENT. THE DAMAGED SCLERAL TISSUE WAS OBSERVED AT THE PATIENT'S 1-DAY POST-OPERATIVE FOLLOW UP AT WHICH TIME THE PATIENT WAS HOSPITALIZED TO TREAT THE INJURY, REPORTEDLY WITH "A SUTURE". THE REPORT WAS PROVIDED BY IRIDEX'S DISTRIBUTOR ON BEHALF OF THE ATTENDING PHYSICIAN.
Patient problems: Patient Problem/Medical Problem
MAUDE report 8339298 ↗InjurySep 21, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
PHYSICIAN THAT PERFORMED THE PROCEDURE DID NOT HAVE PREVIOUS EXPERIENCE WITH THE IRIDEX DEVICES MICROPULSE3 (MP3) PROBE NOR THE CYCLO G6; THE OPERATING NURSE HAD STATED TO THE PHYSICIAN THEY KNEW HOW TO SET UP THE CYCLO G6 CONSOLE FOR SURGERY. PATIENT WAS GIVEN A RETROBULBAR ANESTHESIA FOR THE PROCEDURE AND THE LASER WAS SET UP BY THE NURSE FOR A CONTINUOUS WAVE (CW) PROCEDURE AND PLUGGED IN A G-PROBE DELIVERY DEVICE; THE PROCEDURE WAS INTENDED TO BE PERFORMED IN MICROPULSE MODE. THE PHYSICIAN ACCEPTED THE G-PROBE FROM THE NURSE AND TREATED THE PATIENTS. THE CYCLO G6 CONSOLE SETTINGS WERE: 2000MW / 2000MS / 250 INTERVAL. THE PHYSICIAN DID NOTICE A DIFFERENCE IN DELIVERY DEVICE (MP3 PROBE COMPARED TO A G-PROBE) AND DECIDED TO PROCEED WITH THE PROCEDURE. WHILE THE TREATING PHYSICIAN WAS SWEEPING THE SUPERIOR ASPECT OF THE EYE, IN CONTINUOUS WAVE MODE, HE BEGAN TO SEE CONJUNCTIVAL SHRINKAGE AND SCLERAL BURNS OCCUR. HE TREATED FOR A DURATION OF 50 SECONDS TOTAL OVER MANY SPOTS DESPITE NOTING COMPLICATIONS CONTINUED TO TREAT THE INFERIOR ASPECT OF THE EYE IN THE SAME MANNER. AFTER THE PROCEDURE WAS COMPLETED, AND THE PHYSICIAN QUESTIONED THE NURSE AND REALIZED THE DELIVERY DEVICES WERE
Patient problems: Visual Impairment
MAUDE report 7900061 ↗
Other Powered Laser Surgical Instrument devices
- Moxy 0010-2400Boston Scientific Corporation · Powered Laser Surgical Instrument4,572 reports
- SOLTIVE TFL-PLSGyrus ACMI, LLC · Powered laser surgical instrument6 recalls450 reports
- Flexiva TracTip M0068403960Boston Scientific Corporation · Powered laser surgical instrument562 reports
- Moses™ AC-10030100Lumenis Ltd. · Powered Laser Surgical Instrument532 reports
- Flexiva M0068403910Boston Scientific Corporation · Powered laser surgical instrument376 reports
- Visualase 9735542Medtronic Navigation, Inc. · Powered laser surgical instrument1 recall2 deaths311 reports
- SOLTIVE TFL-SLSGyrus ACMI, LLC · Powered laser surgical instrument6 recalls33 reports
- NeuroBlate® System 20980Monteris Medical Inc · Powered laser surgical instrument7 deaths296 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page