MicroPulse P3 Device Box of 6 15522Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00813125016630), received between Jul 15, 2022 and Jun 13, 2024 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJun 13, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  AN ADVERSE EVENT WAS REPORTED TO IRIDEX OF A PATIENT EXPERIENCING A SCLERAL BURN DURING TREATMENT WITH THE MICROPULSE P3 PROBE DELIVERY DEVICE. NO ADDITIONAL INFORMATION REGARDING THE ADVERSE EVENT IS AVAILABLE. IRIDEX IS CURRENTLY INVESTIGATING THE ADVERSE EVENT AND HAS CONTACTED THE COMPLAINANT TO GET FURTHER INFORMATION OF THE INCIDENT THAT OCCURRED.

  Patient problems: Eye Burn; Eye Injury

  MAUDE report 19534044 ↗
• MalfunctionJun 13, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO IRIDEX THAT WHILE USING THE MICROPULSE P3 PROBE, THE PROBE "POPPING SOUND OCCURRED DURING TREATMENT AND PROBE BURNED OUT". NO OTHER ADDITIONAL INFORMATION REGARDING THIS EVENT WAS PROVIDED TO IRIDEX. THIS IS A POSSIBLE MALFUNCTION OF THE DELIVERY DEVICE THAT MAY CAUSE OR CONTRIBUTE TO A SERIOUS INJURY IF THE MALFUNCTION WERE RECUR. IRIDEX IS INVESTIGATING THIS COMPLAINT TO GATHER MORE INFORMATION OF THE EVEN THAT OCCURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19533944 ↗
• InjuryMay 12, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  FOLLOW UP REPORT: 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) REPORT D: UPDATES TO SECTION D8, D9. 3) PART H: UPDATE TO INCLUDE THAT THIS A CORRECTION REPORT. 4) PART D: UPDATED THIS SECTION WITH THE UDI NUMBER. 5) PART E: UPDATES TO THE INITIAL REPORTER SECTION WITH INFROMATION REGARDING THE COMPLAINANT. THE FOLLOWING TEXT WERE PROVIDED IN THE INITIAL REPORT: IRIDEX BECAME AWARE OF A PATIENT EXPERIENCING SCLERAL BURN DURING TREATMENT WITH A MICROPULSE P3 PROBE. THE TREATMENT SETTINGS USE WERE WITHIN SPECIFICATIONS. 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. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS MOMENT. IRIDEX WILL CONTINUE TO FOLLOW-UP WITH THE DOCTOR FOR INFORMATION REGARDING PATIENT RECOVERY.

  Patient problems: Eye Burn

  MAUDE report 16924118 ↗
• InjuryApr 26, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  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: REPORT C: IS THIS A COMBINATION PRODUCT - NO. PART H: UPDATE TO INCLUDE THAT THIS A CORRECTION REPORT PART D: UPDATE THE LOT NUMBER INFORMATION. THE LOT NUMBER WAS FILLED OUT IN THE SECTION FOR SERIAL NUMBER. UPDATED THIS SECTION WITH THE UDI NUMBER. PART E: UPDATES TO THE INITIAL REPORTER SECTION WITH INFROMATION REGARDING THE COMPLAINANT PART H4: UPDATES TO DATE OF MANUFACTURE. THIS INFORMATION WAS NOT SUBMITTED PREVIOUSLY THE FOLLOWING TEXT WERE PROVIDED IN THE INITIAL REPORT: IRIDEX BECAME AWARE OF A PATIENT EXPERIENCING SCLERAL BURN DURING TREATMENT WITH A MICROPULSE P3 PROBE. BASED ON THE INFORMATION PROVIDED AND SIMILAR ADVERSE EVENTS, THE MOST LIKELY CAUSE OF THE ISSUE IS SUSPECTED TO BE CONTAMINATION ON THE PROBE TIP WHEN THE LASER WAS ACTIVATED OR LASER ACTIVATION WHEN THE PROBE IS OVER PIGMENTED CONJUNCTIVAL TISSUE. 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

  Patient problems: Eye Burn

  MAUDE report 16818112 ↗
• InjurySep 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IRIDEX BECAME AWARE OF A PATIENT EXPERIENCING BURN MARKS DURING TREATMENT WITH A CYCLO G6 LASER SYSTEM IN COMBINATION WITH A G-PROBE DELIVERY DEVICE. ENGINEERING FAILURE ANALYSIS WAS PERFORMED AND THE PRESENCE OF CONTAMINATION COULD NOT BE IDENTIFIED ON THE PROBE TIP. THE EXACT ROOT CAUSE IS UNKNOWN. HOWEVER; PER THE IFU, 'SCLERAL BURNS ARE NOT TYPICAL AND MAY INDICATE CONTAMINATION AT THE DEVICE TIP. THE IFU ALSO INSTRUCTS THE USER TO DISCONTINUE USE AND REPLACE THE DEVICE IMMEDIATELY IF A SCLERAL BURN OCCURS. THE FACT THAT MULTIPLE BURNS WERE REPORTED SUGGESTS THAT THE DEVICE TIP BECAME CONTAMINATED WITH TISSUE OR BLOOD DURING USE AND THAT THE CONTAMINATION WAS'NT OBSERVED AND THE TREATMENT WAS CONTINUED. THE G-PROBE IFU PROVIDES INSTRUCTIONS FOR MAINTAINING CLEANLINESS OF THE DEVICE TIP AND RELATED CAUTIONS ON PAGE 1' KEEP THE DEVICE TIP CLEAN TO MINIMIZE THE RISK OF BURNS TO THE OCULAR SURFACE. IF THE TIP ACCUMULATES DEBRIS OR "CHARRING" DURING THE PROCEDURE, CLEAN IT GENTLY WITH AN ALCOHOL SWAB.IF THE "CHARRING" OR DISCOLORATION ON THE TIP CANNOT BE REMOVED BY GENTLE CLEANING, DISCARD THE DEVICE. THE IFU ALSO CONTAINS A WARNING REGARDING POTENTIAL HARM THAT MAY RESULT FROM USE

  Patient problems: Eye Burn

  MAUDE report 15514539 ↗
• InjuryJul 29, 2022Adverse Event Without Identified Device or Use Problem

  IRIDEX BECAME AWARE OF TWO PATIENTS EXPERIENCING CONJUNCTIVAL BURN ON THE EYE DURING TREATMENT WITH A MICROPULSE P3 DELIVERY DEVICE. THE TREATMENT SETTINGS WERE WITHIN SPECIFICATIONS. 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 15135552 ↗
• InjuryJul 15, 2022Adverse Event Without Identified Device or Use Problem

  IRIDEX BECAME AWARE OF A PATIENT EXPERIENCING CONJUNCTIVAL DURING TREATMENT WITH A CYCLO G6 LASER SYSTEM IN COMBINATION WITH THE MICROPULSE P3 PROBE. 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. ENGINEERING FAILURE ANALYSIS COULD NOT BE PERFORMED BECAUSE THE DEVICE WAS NOT RETURNED FOR EVALUATION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS MOMENT. IRIDEX WILL CONTINUE TO FOLLOW-UP WITH THE DOCTOR FOR INFORMATION REGARDING PATIENT RECOVERY.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 15028819 ↗