MicroPulse® P3 Device Single 15522-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00813125015251), received between Feb 14, 2019 and Dec 23, 2025 — classified as 27 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (9 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 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• InjuryDec 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IRIDEX BECAME AWARE OF A PATIENT THAT EXPERIENCED A CONJUNCTIVAL BURN DURING TREATMENT WITH THE MICROPULSE P3 PROBE DELIVERY DEVICE. THERE IS NO ADDITIONAL INFORMATION REGARDING THE REPORTED ADVERSE EVENT. THERE WAS NO RECORD OF THE COMPLAINANT OR REPORTER INFORMATION. IT IS UNKNOWN IF THE EVENT WAS CAUSED BY A USER OR DEVICE RELATED. DEVICE WAS NOT RETURNED TO IRIDEX FOR FURTHER INVESTIGATION. NO TREATMENT PARAMETERS OR PATIENT RELATED INFORMATION WAS SHARED TO REACH A CONCLUSIVE FINDING. 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 AS A POSSIBLE COMNPLICATION IN THE IFU FOR MP3 DELIVERY DEVICE. CONJUNCTIVAL BURNS ARE A SPECIFIC TYPE OF OCULAR BURN THAT CAN OCCUR ALONG WITH CORNEAL BURNS, OFTEN DUE TO CHEMICAL OR THERMAL INJURY AND ARE TYPICALLY SUPERFICIAL, POSING NO LONG-TERM THREAT TO THE PATIENT. TYPICALLY, THESE BURNS RESOLVE WITHIN 24-48 HOURS POST OP WITHOUT ADDITIONAL INTERVENTION. IRIDEX CORPORATION

  Patient problems: Eye Injury

  MAUDE report 23884116 ↗
• InjuryDec 23, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  A CONJUNCTIVAL BURN INCIDENT AT SCA ORANGE COAST SURGERY CENTER WAS REPORTED TO IRIDEX. THE PROCEDURE WAS PERFORMED USING THE IRIDEX MICROPULSE P3 PROBE (MP3). NO INFORMATION ON THE LASER CONSOLE USED WAS PROVIDED TO IRIDEX. THERE WAS NO DEVICE RETURNED TO IRIDEX TO REACH A CONCLUSIVE FINDING FOR THE REPORTED EVENT. TYPICALLY PROBES NOT SERVICED BY IRIDEX AND ARE CONSIDERED BIOHAZARDOUS ONCE USED. IT IS RECOMMENDED TO DISCARD THEM POST TREATMENT ON A PATIENT. TREATMENT PARAMETERS WERE PROVIDED TO IRIDEX: 2500MW, 20S SWEEPS PERFORMED 6 SWEEPS WHICH ARE IN LINE WITH THE IFU RECOMMENDED PARAMETERS. 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 THE IFU FOR MP3 DELIVERY DEVICE. CONJUNCTIVAL BURNS ARE A SPECIFIC TYPE OF OCULAR BURN THAT CAN OCCUR ALONG WITH CORNEAL BURNS, OFTEN DUE TO CHEMICAL OR THERMAL INJURY AND ARE TYPICALLY SUPERFICIAL, POSING NO LONG-TERM THREAT TO THE PATIENT. TYPICALLY, THESE BURNS RESOLVE

  Patient problems: Eye Injury

  MAUDE report 23882141 ↗
• InjuryDec 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IRIDEX WAS NOTIFIED OF A PATIENT EXPERIENCING MACULAR EDEMA DURING A PROCEDURE USING MICROPULSE P3 PROBE (MP3 PROBE). THE CONDITION CAUSED TEMPORARY VISUAL DISTURBANCE BUT RESOLVED WITHOUT ADDITIONAL TREATMENT. THE DOCTOR INDICATED IT WAS LIKELY A KNOWN COMPLICATION OF THE PROCEDURE, NOT A DEVICE MALFUNCTION. DEVICE WAS NOT RETURNED TO IRIDEX FOR FURTHER INVESTIGATION. IRIDEX TAKES PROACTIVE APPROACH IN NOTIFYING FDA REGARDING ANY ADVERSE EVENTS AND HENCE A MEDWATCH (3500A) FORM IS BEING SUBMITTED FOR THIS ADVERSE EVENT.

  Patient problems: Eye Injury

  MAUDE report 23831832 ↗
• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IRIDEX BECAME AWARE OF A PATIENT INCIDENT INVOLVING A CONJUNCTIVAL BURN REPORTED BY PHYSICIAN SURGERY CENTER OF ALBUQUERQUE USING A MICROPULSE P3 PROBE AND CYCLO G6 LASER CONSOLE. CYCLO G6 LASER CONSOLE RETURNED TO IRIDEX FOR SERVICING. DURING TECHNICAL INSPECTION, THE CONSOLE PASSED VISUAL INSPECTION AND RFID JUMPER FIBER DETECTION. NO ERROR CODES INDICATING MALFUNCTION WERE DISPLAYED. THE LASER CONSOLE ALSO PASSED THE POWER REQUIREMENTS, AND NO ANOMALIES WERE OBSERVED. PROBES NOT RETURNED TO IRIDEX FOR TECHNICAL INSPECTION. PROBES NOT SERVICED BY IRIDEX AND ARE CONSIDERED BIOHAZARDOUS ONCE USED. IT IS RECOMMENDED TO DISCARD THEM POST TREATMENT ON A PATIENT. CONJUNCTIVAL BURNS ARE A KNOWN POTENTIAL HARM ASSOCIATED WITH THE USE OF LASER DELIVERY IN OPHTHALMIC INDICATIONS. POSSIBILITY OF CONJUNCTIVAL BURN ARE LISTED IN BOTH THE IFU INCLUDED IN MP3 DELIVERY DEVICE AS WELL AS WITHIN THE CYCLO G6 LASER OPERATING MANUAL DUE TO HEATING UP THE TIP OF THE PROBE USED TO DELIVERY THE LASER POWER. THE PROCEDURE WAS PERFORMED USING A TREATMENT SETTING OF 2250 MW WITH AN EXPOSURE TIME OF 15-20 SECONDS PER HEMISPHERE, APPLYING 4-5 SWEEPS. THESE PARAMETERS FALL WITHIN THE RANGE SUGGESTED IN THE M

  Patient problems: Eye Injury

  MAUDE report 23818842 ↗
• InjuryDec 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IRIDEX BECAME AWARE OF A PATIENT INCIDENT (CONJUNCTIVAL BURN) USING THE IRIDEX MICROPULSE P3 PROBE (MP3). NO INFORMATION ON THE LASER CONSOLE USED WAS PROVIDED TO IRIDEX. NO DEVICE WAS RETURNED TO IRIDEX FOR SERVICING. PROBE ARE SINGLE USE DEVICES AND ARE CONSIDERED BIOHAZARDOUS ONCE USED. IT IS RECOMMENDED TO DISCARD THEM POST TREATMENT ON A PATIENT. 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 AS A POSSIBLE COMPLICATION IN THE IFU FOR MP3 DELIVERY DEVICE. CONJUNCTIVAL BURNS ARE A SPECIFIC TYPE OF OCULAR BURN THAT CAN OCCUR ALONG WITH CORNEAL BURNS, OFTEN DUE TO CHEMICAL OR THERMAL INJURY AND ARE TYPICALLY SUPERFICIAL, POSING NO LONG-TERM THREAT TO THE PATIENT. TYPICALLY, THESE BURNS RESOLVE WITHIN 24-48 HOURS POST OP WITHOUT ADDITIONAL INTERVENTION. IRIDEX CORPORATION DOES REPORT EVERY ADVERSE EVENT VIA THE FDA'S MANUFACTURER AND USER FACILITY DEVICE EXPERIENCE (MAUDE) DATABASE. DURING A CBLT PROCEDURE AT NW

  Patient problems: Eye Injury

  MAUDE report 23812051 ↗
• InjuryDec 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024, DURING A TRANSSCLERAL LASER TREATMENT FOR GLAUCOMA USING IRIDEX MICROPULSE P3 PROBE, THE PATIENT SUSTAINED A CONJUNCTIVAL BURN. THE PHYSICIAN IMMEDIATELY STOPPED THE PROCEDURE, REPLACED THE PROBE, AND COMPLETED THE TREATMENT WITHOUT FURTHER COMPLICATIONS. THE PHYSICIAN SUSPECTED THE INITIAL PROBE WAS DEFECTIVE. DEVICE WAS NOT RETURNED TO IRIDEX FOR FURTHER INVESTIGATION. 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 AS A POSSIBLE COMPLICATION IN THE IFU FOR MP3 DELIVERY DEVICE. CONJUNCTIVAL BURNS ARE A SPECIFIC TYPE OF OCULAR BURN THAT CAN OCCUR ALONG WITH CORNEAL BURNS, OFTEN DUE TO CHEMICAL OR THERMAL INJURY AND ARE TYPICALLY SUPERFICIAL, POSING NO LONG-TERM THREAT TO THE PATIENT. TYPICALLY, THESE BURNS RESOLVE WITHIN 24-48 HOURS POST OP WITHOUT ADDITIONAL INTERVENTION. IRIDEX CORPORATION DOES REPORT EVERY ADVERSE EVENT VIA THE FDA'S MANUFACTURER AND USER FACILITY DEVICE EXPERIENCE (MAUDE) DAT

  Patient problems: Eye Injury

  MAUDE report 23774011 ↗
• InjuryDec 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO IRIDEX THAT WHILE USING THE MICROPULSE P3 PROBE, A PHYSICIAN NOTICED SMOKE COMING OUT OF THE PROBE TIP AND THE PHYSICIAN NOTICED CONJUNCTIVAL BURN. DEVICE WAS NOT RETURNED TO IRIDEX FOR FURTHER INVESTIGATION. 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 AS A POSSIBLE COMNPLICATION IN THE IFU FOR MP3 DELIVERY DEVICE. CONJUNCTIVAL BURNS ARE A SPECIFIC TYPE OF OCULAR BURN THAT CAN OCCUR ALONG WITH CORNEAL BURNS, OFTEN DUE TO CHEMICAL OR THERMAL INJURY AND ARE TYPICALLY SUPERFICIAL, POSING NO LONG-TERM THREAT TO THE PATIENT. TYPICALLY, THESE BURNS RESOLVE WITHIN 24-48 HOURS POST OP WITHOUT ADDITIONAL INTERVENTION. IRIDEX CORPORATION DOES REPORT EVERY ADVERSE EVENT VIA THE FDA'S MANUFACTURER AND USER FACILITY DEVICE EXPERIENCE (MAUDE) DATABASE. THE TREATMENT PARAMETERS REPORTED (1500 MW POWER, 1500 MS PER SWEEP, 5 SWEEPS PER QUADRANT) DIFFER SIGNIFICANTLY FROM THE PARAMETERS SUGGESTED IN THE MP3

  Patient problems: Eye Injury

  MAUDE report 23770008 ↗
• InjuryDec 9, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  A PATIENT BURN INCIDENT AFTER BLEEDING FROM A TORN CONJUNCTIVA THAT OCCURRED AT (B)(6) WAS REPORTED TO IRIDEX ON (B)(6) 2024. THE PROCEDURE WAS PERFORMED USING THE IRIDEX MICROPULSE P3 PROBE (MP3). TYPICALLY PROBES NOT SERVICED BY IRIDEX AND ARE CONSIDERED BIOHAZARDOUS ONCE USED. IT IS RECOMMENDED TO DISCARD THEM POST TREATMENT ON A PATIENT. THE INCIDENT REPORTED A BURN TO THE PATIENT IN THE 4TH QUADRANT OF THE EYE AFTER BLEEDING WAS OBSERVED FROM A TORN CONJUNCTIVA. THREE FOLLOW-UP EMAILS WERE SENT TO THE CUSTOMER REQUESTING ADDITIONAL INFORMATION REGARDING THE REPORTED PATIENT BURN; HOWEVER, UNCLEAR RESPONSE HAS BEEN RECEIVED. A FOLLOW UP WAS DONE AGAIN ON THE UNCLEAR RESPONSE, NO FEEDBACK WAS RECEIVED TO PROVE MORE DETAILS ON THE EVENT. 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 L

  Patient problems: Eye Injury

  MAUDE report 23759449 ↗
• MalfunctionFeb 7, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IRIDEX BECAME AWARE OF A PATIENT INCIDENT THAT OCCURRED AT VALLEY LASER AND SURGERY CENTER INVOLVING AN IRIDEX MICROPULSE P3 DEVICE. IT WAS REPORTED THAT THE MP3 DEVICE HAD POPPED AND CHARRED AT THE END OF THE PROBE DURING A PATIENT PROCEDURE. THE PATIENT WAS GIVEN AN ANESTHESIA AND WAS UNDER MILD SEDATION. THERE WAS NO REPORTED PATIENT IMPACT OR ADVERSE EFFECTS AS A RESULT OF THE INCIDENT. IT IS UNKNOWN IF THE PATIENT HAD ANY UNDERLYING CONDITIONS OR DISEASE STATES AT THE TIME OF THE INCIDENT. NO OTHER PATIENT INFORMATION WAS PROVIDED. THE PROCEDURE WAS COMPLETED WITH NO OTHER REPORTED INJURIES OR COMPLICATIONS.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21337602 ↗
• InjuryJun 15, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  AN ADVERSE EVENT WAS REPORTED TO IRIDEX OF A PATIENT EXPERIENCING A CONJUNCTIVAL AND SCLERAL PIGMENTATION. NO FURTHER INFORMATION IS AVAILABLE. IRIDEX IS CURRENTLY INVESTIGATING THIS COMPLAINT AND HAS CONTACTED THE COMPLAINANT TO GATHER MORE INFORMATION.

  Patient problems: Eye Injury

  MAUDE report 19544132 ↗
• InjuryJun 14, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO IRIDEX THAT A PATIENT EXPERIENCED A SCLEARL BURN DUING TREATMENT WITH THE MICROPULSE P3 PROBE DELIVERY DEVICE. THERE IS NO ADDITIONAL INFORMATION REGARDING THE REPORTED ADVERSE EVENT. THE ADVERSE EVENT IS CURRENTLY BEING INVESTIGATED AND IRIDEX HAS CONTACTED THE COMPLAINANT TO GATHER FURTHER INFORMAITON OF THE REPORTED ADVERSE EVENT.

  Patient problems: Eye Burn

  MAUDE report 19542539 ↗
• InjuryJun 14, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO IRIDEX THAT A PATIENT SNEEZED AND EXPERIENCED A SLIGHT CONJUNCTIVAL TEAR DURING TREATMENT WITH THE MICROPULSE P3 DELIVERY DEVICE. NO OTHER INFORMATION WAS PROVIDED TO IRIDEX REGARDING THE ADVERSE EVENT. DUE TO THE LIMITED INFORMATION IT IS UNKNOWN WHETHER THE DEVICE PERFORMANCE MAY HAVE LED TO THE PATIENT INJURY. IRIDEX IS CURRENTLY INVESTIGATING THE COMPLAINT AND WILL REACH OUT TO THE COMPLAINANT TO GATHER MORE INFORMATION OF THE REPORTED ADVERSE EVENT.

  Patient problems: Eye Injury

  MAUDE report 19541668 ↗
• InjuryJun 14, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  A PATIENT EXPERIENCED A EPITHELIAL CORNEA DEFECT ONE WEEK POST-OP AFTER RECEIVING TREATMENT WITH MICROPULSE P3 PROBE DELIVERY DEVICE. NO FURTHER INFORMATION WAS PROVIDED BY THE COMPLAINANT REGARDING THE ADVERSE EVENT. IRIDEX IS CURRENTLY INVESTIGATING THE COMPLAINT AND HAS REACHED OUT TO THE CUSTOMER FOR FURTHER INFORMATION.

  Patient problems: Eye Injury

  MAUDE report 19539090 ↗
• InjuryJun 13, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  AN ADVERSE EVENT WAS REPORTED TO IRIDEX OF A PATIENT EXPERIENCING CONJUNCTIVAL BURNS WHILE BEING TREATED WITH THE MICROPULSE P3 PROBE DELIVERY DEVICE AND THE CYCLO G6 LASER SYSTEM. IT WAS REPORTED THAT A PROBE MALFUNCTION CAUSED THE CONJUNCTIVAL BURNS. THE USER SWITCHED TO A NEW PROBE AND WAS ABLE TO COMPLETE THE PROCEDURE WITHOUT FURTHER INCIDENT REPORTED. NO OTHER ADDITIONAL INFORMATION WAS PROVIDED TO IRIDEX ABOUT THE ADVERSE EVENT, INCLUDING THE SPECIFIC DEVICE MALFUNCTION WAS NOT REPORTED. GIVEN THE LIMITED INFORMATION REPORTED TO IRIDEX IT IS CURRENTLY UNKNOWN HOW DEVICE PERFORMANCE MAY HAVE CAUSED OR CONTRIBUTED TO THE CONJUNCTIVAL BURNS. IRIDEX IS CURRENTLY INVESTIGATING THE COMPLAINT AND HAS CONTACTED THE COMPLAINANT TO GATHER MORE INFORMATION.

  Patient problems: Eye Burn; Eye Injury

  MAUDE report 19534141 ↗
• InjuryApr 23, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  A 37 YEAR OLD, MALE PATIENT WITH A KNOWN HISTORY OF SEVERE PRIMARY OPEN ANGLE GLAUCOMA EXPERIENCED A CONJUNCTIVAL BURN IN THE LEFT EYE DURING TREATMENT WITH MICROPULSE P3 PROBE DELIVERY DEVICE. GENERAL ANESTHETIC WAS USED DURING THE PROCEDURE, AND NO VASOCONSTRICTOR WAS USED. A BETADINE SOLUTION WAS USED IN THE SURGICAL FIELD AND THE FOLLOWING LIQUID INTERFACE WAS USED, OPHTHALMIC GEL. THE FOLLOWING TREATMENT WAS USED DURING THE TREATMENT: POWER SETTINGS : 25000 MW-100SX2, SWEEP SPEED VELOCITY 31.2%, HEMISPHERE TECHNIQUE AND MINIMAL PRESSURE WAS USED WHILE SWEEPING WITH THE DELIVERY DEVICE. THERE WAS NO SUBCONJUNCTIVAL HEMORRHAGE OR BLEEDING PRESENT IN THE SURGICAL FIELD DURING THE PROCEDURE. THERE WERE PIGMENTED LEGIONS/DARK AREAS OF PIGMENTATION PRESENT IN THE SURGICAL FIELD.

  Patient problems: Eye Burn; Eye Injury

  MAUDE report 19166794 ↗
• InjuryJul 24, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IRIDEX BECAME AWARE OF A COMPLAINT REPORTING A BURN DURING TREATMENT WITH A MICROPULSE P3 PROBE. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED, AND NO ADDITIONAL INFORMATION HAS BEEN PROVIDED BY THE CLINIC OR TREATING PHYSICIAN. THE TREATMENT WAS COMPLETED SUCESSFULLY USING ANOTHER PROBE. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17385525 ↗
• InjuryJun 12, 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 PROVIDED 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: UPDATE THE LOT NUMBER INFORMATION. THE LOT NUMBER WAS FILLED OUT IN THE SECTION FOR SERIAL NUMBER. UPDATED THIS SECTION WITH THE UDI NUMBER. 5) PART E: UPDATES TO THE INITIAL REPORTER SECTION WITH INFORMATION REGARDING THE COMPLAINANT 6) 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. 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 REC

  Patient problems: Eye Burn

  MAUDE report 17109067 ↗
• InjuryFeb 28, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IRIDEX BECAME AWARE OF A COMPLAINT REPORTING A PATIENT EXPERIENCING CONJUNCTIVAL BURN DURING TREATMENT WITH THE MICROPULSE P3 PROBE. 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. FOLLOW-UP INFORMATION FROM THE SURGEON INDICATED THAT THE PATIENT WAS RECOVERING FROM THE BURN. 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, AVOID AREAS OF HEAVY PERILIMBAL PIGMENTATION.' IRIDEX HAS REQUESTED THE CLINIC TO RETURN THE LAS

  Patient problems: Eye Burn

  MAUDE report 16456534 ↗
• InjuryFeb 28, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IRIDEX BECAME AWARE OF A COMPLAINT REPORTING A PATIENT EXPERIENCING A SIZZLE FOLLOWED BY A SMELL DURING TREATMENT WITH THE MICROPULSE P3 PROBE. A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. THE DOCTOR FOLLOWED THE INSTRUCTIONS ON THE MICROPULSE IFU AND IMMEDIATELY STOPPED TREATMENT WITH THE PROBE. THERE WAS NO PATIENT INJURY REPORTED. THE TREATMENT WAS PERFORMED WITHIN SPECIFICATIONS. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16456362 ↗
• InjuryNov 30, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IRIDEX BECAME AWARE OF A PATIENT EXPERIENCING SCLERAL BURN ON THE EYE DURING TREATMENT WITH A MICROPULSE P3 DELIVERY DEVICE. IT IS UNKNOWN IF THE DOCTOR CONTINUED TO USE THE SAME MICROPULSE P3 DEVICE. 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 15885656 ↗
• InjuryAug 18, 2022Adverse Event Without Identified Device or Use Problem

  IRIDEX BECAME AWARE OF A PATIENT EXPERIENCING CONJUNCTIVAL BURN DURING TREATMENT WITH A MICROPULSE P3 DELIVERY DEVICE. THE DOCTOR FOLLOWED THE INSTRUCTIONS ON THE MICROPULSE P3 IFU AND STOPPED THE TREATMENT AFTER THIS INITIAL BURN WAS OBSERVED. 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 15255541 ↗
• InjuryAug 18, 2022Adverse Event Without Identified Device or Use Problem

  IRIDEX BECAME AWARE OF A PATIENT EXPERIENCING BURN ON THE EYE FOLLOWED BY A BURNING SMELL DURING TREATMENT WITH A MICROPULSE DELIVERY DEVICE. THE DOCTOR CONTINUED TO TREAT THE PATIENT AND REPORTED THAT THE PATIENT EXPERIENCED ANOTHER BURN. IT IS UNKNOWN IF THE DOCTOR CONTINUED TO USE THE SAME MICROPULSE DEVICE. 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 15255509 ↗
• InjuryAug 8, 2022Adverse Event Without Identified Device or Use Problem

  IRIDEX BECAME AWARE OF A PATIENT EXPERIENCING BURN ON THE RETINA DURING TREATMENT WITH A MICROPULSE P3 DELIVERY DEVICE. THE TREATMENT SETTINGS WERE WITHIN SPECIFICATIONS. THE DOCTOR CONTINUED TO TREAT THE PATIENT AND REPORTED THAT THE PATIENT EXPERIENCED ANOTHER BURN. IT IS UNKNOWN IF THE DOCTOR CONTINUED TO USE THE SAME MICROPULSE P3 DEVICE. THERE IS NO RESPONSE FROM THE TREATING PHYSICIAN TO EMAILS OR CALLS FROM IRIDEX. 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 15189018 ↗
• InjuryJun 18, 2022Smoking

  IRIDEX BECAME AWARE OF A COMPLAINT REPORTING THAT THE TIP OF THE PROBE BEGAN EMITTING SMOKE DURING THE PROCEDURE AND REPORTED THE PRESENCE OF BURN RINGS ON THE PATIENT'S EYE. THE PROCEDURE WAS PERFORMED USING A MICROPULSE P3 PROBE AND CYCLO G6 LASER SYSTEM. A CONCLUSIVE ROOT CAUSE FOR THIS EVENT WAS NOT DETERMINED. THE TREATMENT SETTINGS WERE WITHIN SPECIFICATIONS. ENGINEERING FAILURE ANALYSIS HAS NOT YET BEEN PERFORMED BECAUSE THE RETURNED PROBE HAS NOT BEEN RECEIVED. FAILURE ANALYSIS WILL BE COMPLETED ONCE THE PROBE IS RECEIVED. IF NEW INFORMATION BECOMES AVAILABLE, THIS RECORD WILL BE AMENDED. 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: Superficial (First Degree) Burn

  MAUDE report 14740053 ↗
• InjuryJan 6, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IRIDEX BECAME AWARE OF A COMPLAINT REPORTING THAT A PATIENT EXPERIENCED A SCLERAL BURN DURING TREATMENT WITH A MICROPULSE P3 PROBE. THE COMPLAINT ALSO REPORTS THE PRESENCE OF BLOOD 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 WITH BLOOD. 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'. THE COMPLAINANT REPORTED THAT NO MALFUNCTION OF THE LASER CONSOLE AND DELIVERY DEVICE WAS OBSERVED. ENGINEERING FAILURE ANALYSIS WAS NOT PERFORMED AS THE MICROPULSE P3 PROBE WAS NOT RETURNED TO IRIDEX BY THE CUSTOMER.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 13177555 ↗