MicroPulse® P3 Device Box of 6 15522Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00813125015244), received between Mar 10, 2022 and Sep 29, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (2 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

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Eye Injury

  MAUDE report 50941362 ↗
• InjuryDec 8, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  A PATIENT BURN INCIDENT THAT OCCURRED AT DUPONT SURGERY CENTER WAS REPORTED TO IRIDEX ON (B)(6) 2024. THE PROCEDURE WAS PERFORMED USING THE CYCLO G6 LASER CONSOLE WITH IRIDEX MICROPULSE P3 PROBE (MP3). THE CYCLO G6 LASER CONSOLE WAS RETURNED TO IRIDEX FOR INVESTIGATION BUT NO PROBLEM WAS FOUND WITH THE LASER CONSOLE DURING MFG TESTED PROCESS. ISSUE WAS RELATED TO PROBE AND NOT UNIT. PROBE WAS NOT RETURNED TO IRIDEX. TYPICALLY PROBES NOT SERVICED BY IRIDEX AND ARE CONSIDERED BIOHAZARDOUS ONCE USED. IT IS RECOMMENDED TO DISCARD THEM POST TREATMENT ON A PATIENT. THREE FOLLOW-UP EMAILS WERE SENT TO THE CUSTOMER REQUESTING ADDITIONAL INFORMATION REGARDING THE REPORTED PATIENT BURN: HOWEVER, NO RESPONSE WASRECEIVED. IN ACCORDANCE WITH STANDARD PROTOCOL, IRIDEX WILL PROCEED WITH PROCESSING THE COMPLAINT BASED ON THE INFORMATION CURRENTLY AVAILABLE. OPHTHALMIC LASER SYSTEMS ARE INTENDED TO DELIVER THERMAL (LASER) ENERGY TO DELIVER AN INSULT (BURN) TO THE CILIARY BODY. CONJUNCTIVAL BURNS ARE A KNOWN AND PREDICTED COMPLICATION ASSOCIATED WITH THE USE OF ANY OPHTHALMIC LASER SYSTEM (CONSOLE AND DELIVERY DEVICE) WHEN USED TO DELIVER TRANSSCLERAL TREATMENT. IT IS LISTED IN BOTH THE IFU INCLUDED

  Patient problems: Eye Injury

  MAUDE report 23744566 ↗
• InjuryMar 31, 2022Adverse Event Without Identified Device or Use Problem

  IRIDEX BECAME AWARE OF A COMPLAINT REPORTING A PATIENT EXPERIENCING AN INTRAOCULAR PRESSURE (IOP) SPIKE FOLLOWED BY A SWOLLEN CORNEA POST TREATMENT. THE DOCTOR REPORTED A DECREASED VISION IN THE PATIENT POST-SURGERY. THE DOCTOR PERFORMED NECESSARY MEDICAL INTERVENTION TO BRING DOWN THE IOP LEVEL. CONSISTENT FOLLOW-UP REGARDING PATIENT CONDITION IS BEING PERFORMED BY AN IRIDEX REPRESENTATIVES. NO ADDITIONAL INFORMATION REGARDING ANY UNDERLYING CONDITIONS HAVE BEEN PROVIDED TO IRIDEX TO DATE. THE DOCTOR SUGGESTED THAT THE PATIENT COULD HAVE POSSIBLY HAD CORNEAL EDEMA BEFORE SURGERY RESULTING IN POST-OPERATIVE COMPLICATIONS. THIS COMPLAINT DID NOT INVOLVE ANY REPORT OF MALFUNCTION OF THE LASER CONSOLE AND PROBE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IRIDEX WILL CONTINUE TO FOLLOW-UP REGARDING THE PATIENT. ENGINEERING FAILURE ANALYSIS WAS NOT PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED.

  Patient problems: Corneal Edema; Intraocular Pressure Increased; Visual Impairment

  MAUDE report 13971918 ↗
• InjuryMar 10, 2022Contamination /Decontamination Problem

  IRIDEX BECAME AWARE OF A COMPLAINT ON (B)(6), 2022 REPORTING A PATIENT EXPERIENCING CONJUNCTIVAL BURN ON (B)(6) 2021 DURING TREATMENT WITH THE MICROPULSE P3 PROBE. THIS COMPLAINT WAS REPORTED TO IRIDEX APPROXIMATELY 2.5 MONTHS AFTER THE INCIDENT OCCURRED. BASED ON THE INFORMATION PROVIDED, IT APPEARS THE TREATMENT WAS PERFORMED WITHIN SPECIFICATIONS. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED AND NO ADDITIONAL INFORMATION HAS BEEN PROVIDED BY THE CLINIC OR TREATING PHYSICIAN. 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 COULD NOT BE PERFORMED BECAUSE THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE RESULTS OF POST MARKET DATA REVIEW INDICATE THAT THIS FAILURE MODE IS NOT OCCURRING WITH GREATER SEVERITY OR FREQUENCY BASED ON THE NUMBER OF EVENTS REPORTED EVALUATED AGAINST THE NUMBER OF CASES PERFORMED.

  Patient problems: Eye Burn

  MAUDE report 13725523 ↗
• InjuryMar 10, 2022Adverse Event Without Identified Device or Use Problem

  IRIDEX BECAME AWARE OF A COMPLAINT ON (B)(6) 2022 REPORTING A PATIENT EXPERIENCING CONJUNCTIVAL BURN ON (B)(6) 2021 DURING TREATMENT WITH THE MICROPULSE P3 PROBE. THIS COMPLAINT WAS REPORTED TO IRIDEX APPROXIMATELY 4.5 MONTHS AFTER THE INCIDENT OCCURRED. BASED ON THE INFORMATION PROVIDED, IT APPEARS THE TREATMENT WAS PERFORMED WITHIN SPECIFICATIONS. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED AND NO ADDITIONAL INFORMATION HAS BEEN PROVIDED BY THE CLINIC OR TREATING PHYSICIAN. 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 COULD NOT BE PERFORMED BECAUSE THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE RESULTS OF POST MARKET DATA REVIEW INDICATE THAT THIS FAILURE MODE IS NOT OCCURRING WITH GREATER SEVERITY OR FREQUENCY BASED ON THE NUMBER OF EVENTS REPORTED EVALUATED AGAINST THE NUMBER OF CASES PERFORMED.

  Patient problems: Eye Burn

  MAUDE report 13725484 ↗
• InjuryMar 10, 2022Contamination /Decontamination 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. THE INCIDENT OCCURRED AT THE BEGINNING OF THE TREATMENT. 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. THE DOCTOR COULD NOT CONFIRM IF THE CONJUNCTIVA WAS PIGMENTED PRIOR TO TREATMENT. 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. HEAVY PERILIMBAL CONJUNCTIVAL PIGMENTATION MAY RESULT IN LOCAL ABSORPTION AND BURNS; THEREFORE, AV

  Patient problems: Eye Burn

  MAUDE report 13725397 ↗