Cyclo G6 Laser ConsoleRecalls & reported problems across all models

We found 2 models of Cyclo G6 Laser Console by Iridex Corporation in the FDA's device registry (GUDID). Together they are named in 20 adverse event reports in the FDA's MAUDE database, received between Sep 21, 2018 and Jul 28, 2026 — classified as 20 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (7 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Cyclo G6 Laser Console problems

Cyclo G6 Laser Console models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Cyclo G6 Laser Console 66245-1

  Powered Laser Surgical Instrument
  14 reports
• Cyclo G6 Laser Console 66245

  Powered Laser Surgical Instrument
  6 reports

Recent Cyclo G6 Laser Console adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported to Iridex that a patient with bilateral secondary glaucoma & bilateral nanophthalmos, underwent MicroPulse transscleral laser treatment using an IRIDEX Cyclo G6 laser console and a MicroPulse P3 (MP3) delivery device. Six months following treatment, the patient was unable to open the treated left eye. Clinical evaluation revealed phthisis bulbi, characterized by significant globe atrophy. Phthisis bulbi is a shrunken, non-functional, and disorganized end-stage ocular condition that may result from severe trauma, chronic inflammation, or infection. It is typically associated with permanent vision loss, hypotony (low intraocular pressure), and structural collapse of the globe.The patient had a pre-existing diagnosis of severe nanophthalmos, a developmental ocular condition characterized by an abnormally small eye due to compromised ocular growth. Nanophthalmos is generally congenital or present from early childhood and is recognized within the spectrum of developmental eye disorders.According to the MP3 Probe Instructions for Use (IFU), the probe tip protrudes 0.4 mm from the handpiece and is specifically designed to facilitate accurate positioning of the fiber-optic

  Patient problems: Visual Disturbances

  MAUDE report 50059856 ↗
• InjuryOct 14, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IRIDEX BECAME AWARE OF A PATIENT EXPERIENCING CONJUNCTIVAL BLANCHING DURING TREATMENT WITH A CYCLO G6 LASER SYSTEM. THE DELIVERY DEVICE USED FOR THE TREATMENT IS UNKNOWN. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED, AND NO ADDITIONAL INFORMATION HAS BEEN PROVIDED BY THE CLINIC OR TREATING PHYSICIAN. ENGINEERING FAILURE ANALYSIS COULD NOT BE PERFORMED BECAUSE THE DEVICE WAS NOT RETURNED FOR EVALUATION. IRIDEX WILL CONTINUE TO FOLLOW-UP WITH THE DOCTOR FOR INFORMATION REGARDING PATIENT RECOVERY.

  Patient problems: Eye Burn

  MAUDE report 15608036 ↗
• InjuryJul 15, 2022Insufficient Device Problem Information

  IRIDEX BECAME AWARE OF A PATIENT EXPERIENCING CHARRING ON THE EYE DURING TREATMENT WITH A CYCLO G6 LASER SYSTEM. THE DELIVERY DEVICE THAT WAS USED IN COMBINATION WITH THE CYCLO G6 IS UNKNOWN, AND NO RESPONSE WAS PROVIDED BY THE CUSTOMER TO IRIDEX FOLLOW-UP EMAILS. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED, AND NO ADDITIONAL INFORMATION HAS BEEN PROVIDED BY THE CLINIC OR TREATING PHYSICIAN. ENGINEERING FAILURE ANALYSIS COULD NOT BE PERFORMED BECAUSE THE DEVICE WAS NOT RETURNED FOR EVALUATION. IRIDEX WILL CONTINUE TO FOLLOW-UP WITH THE DOCTOR FOR INFORMATION REGARDING PATIENT RECOVERY.

  Patient problems: Eye Injury

  MAUDE report 15028823 ↗
• InjuryMay 27, 2022Adverse Event Without Identified Device or Use Problem

  IRIDEX BECAME AWARE OF A COMPLAINT REPORTING A PATIENT EXPERIENCING CONJUNCTIVAL BURN DURING TREATMENT WITH THE MICROPULSE P3 PROBE. THE TREATMENT WAS PERFORMED WITHIN SPECIFICATIONS. A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. BASED ON SIMILAR REPORTED EVENTS, THE MOST LIKELY CAUSE OF THE ISSUE IS SUSPECTED TO BE CONTAMINATION (E.G. BLOOD, TISSUE OR BETADINE) ON THE PROBE TIP WHEN THE LASER WAS ACTIVATED OR LASER ACTIVATION WHEN THE PROBE IS OVER PIGMENTED CONJUNCTIVAL TISSUE. ENGINEERING FAILURE ANALYSIS WAS NOT PERFORMED BECAUSE THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE MICROPULSE P3 IFU HAS CLEAR INSTRUCTIONS TO EXAMINE THE PROBE TIP BEFORE TREATMENT AND TO AVOID AREAS OF PERILIMBAL PIGMENTATION. 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. IF THE DEVICES ARE RETURNED AND THE RESULTS OF FAILURE ANALYSIS INDICATE NEW INFORMATION, THE ADVERSE EVENT REPORT WILL BE AMENDED. THE RESULTS OF POST MARKET DATA REVIEW INDICATE THAT THIS FAILURE MODE IS NOT OCCURRING WITH GREATER SEVE

  Patient problems: Eye Burn

  MAUDE report 14528471 ↗
• 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 ↗
• InjuryFeb 12, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IRIDEX RECEIVED A REPORT THERE WERE TWO PATIENTS THAT HAD SUFFERED FROM MYDRIASIS; ONE SUFFERED FROM CHRONIC MYDRIASIS AND THE OTHER LONG-TERM MYDRIASIS. THE PATIENTS DEVELOPED MYDRIASIS AFTER TREATMENT FROM A MICROPULSE P3 DEVICE WITH A CYCLO G6 LASER CONSOLE.

  Patient problems: Visual Impairment

  MAUDE report 9703498 ↗

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