MicroPulse P3 Device SingleRecalls & reported problems across all models

We found 2 models of MicroPulse P3 Device Single by Iridex Corporation in the FDA's device registry (GUDID). Together they are named in 47 adverse event reports in the FDA's MAUDE database, received between Feb 14, 2019 and Apr 21, 2026 — classified as 45 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (13 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 MicroPulse P3 Device Single problems

MicroPulse P3 Device Single models

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

• MicroPulse® P3 Device Single 15522-1

  Powered Laser Surgical Instrument
  28 reports
• MicroPulse P3 Device Single 15522-1

  Powered Laser Surgical Instrument
  19 reports

Recent MicroPulse P3 Device Single adverse event reports

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

• InjuryApr 21, 2026Use of Device Problem

  IT WAS REPORTED TO IRIDEX THAT WHILE USING THE MICROPULSE P3 PROBE (MP3 PROBE), THE PATIENT EXPERIENCED CONJUNCTIVAL BURN. THE REPORTED SETTINGS USED FOR TREATMENT WERE CONSISTENT WITH THE IFU RECOMMENDATION OF FOUR 20-SECOND PASSES PER HEMISPHERE; POWER: 2500 MV. NO PERMANENT IMPAIRMENT WAS REPORTED TO IRIDEX, AND NO MEDICAL INTERVENTION ASSOCIATED WITH THE BURN WAS REPORTED TO IRIDEX. THE PROBE, WHICH IS DISPOSABLE, WAS NOT RETURNED TO IRIDEX FOR FURTHER INVESTIGATION. ALSO, PROBES ARE NOT SERVICED BY IRIDEX SINCE THEY ARE SINGLE USE AND IF THE PROBES ARE USED DURING TREATMENT, IT IS RECOMMENDED TO DISPOSE THEM AS THEY BECOME BIOHAZARD. ALSO, IT WAS REPORTED THAT THE PROBE TIP WAS BURNED. AS PER THE IFU, THE USER IS INFORMED TO INSPECT THE PROBE FOOTPLATE FOR DEBRIS OR "CHARRING" AND CONFIRM GEL IS ADEQUATELY PRESENT AFTER THE TREATMENT OF A HEMISPHERE. IF THE PROBE TIP ACCUMULATES DEBRIS OR "CHARRING" DURING THE PROCEDURE, THE USER IS INSTRUCTED TO CLEAN IT GENTLY WITH STERILE GAUZE AND A SALINE SOLUTION. THE DEVICE TIP NEEDS TO BE KEPT CLEAN TO MINIMIZE THE RISK OF BURNS TO THE OCULAR SURFACE. AFTER CLEANING THE TIP, THE USER IS REQUIRED TO RE-APPLY A DROP OF METHYLCELLULOSE GE

  Patient problems: Eye Injury

  MAUDE report 24942460 ↗
• InjuryFeb 19, 2026Use of Device Problem

  IT WAS REPORTED TO IRIDEX THAT WHILE USING THE MICROPULSE P3 DELIVERY DEVICE (MP3 PROBE) ALONG WITH CYCLO G6 LASER CONSOLE, THE PATIENT EXPERIENCED CONJUNCTIVAL BURN. IRIDEX MP3 PROBES ARE STERILE, SINGLE USE DELIVERY DEVICES AND ARE RECOMMENDED TO BE DISCARDED POST USE PER THE OPERATOR MANUAL. NEITHER THE MP3 PROBE NOR THE CYCLO G6 LASER CONSOLE WAS NOT RETURNED TO IRIDEX FOR FURTHER INVESTIGATION IN THIS CASE. CONJUNCTIVAL BURNS ARE A KNOWN POTENTIAL HARM ASSOCIATED WITH THE USE OF LASER DELIVERY IN OPHTHALMIC INDICATIONS. PER THE COMPLAINT RECEIVED, THE PROBE TIP WAS CHARRED. OPHTHALMIC LASER SYSTEMS ARE INTENDED TO DELIVER THERMAL (LASER) ENERGY TO DELIVER AN INSULT (BURN) TO THE CILIARY BODY. THE MOST LIKELY CAUSE OF THE REPORTED ADVERSE EVENT IS SUSPECTED TO BE CONTAMINATION (E.G., BLOOD, TISSUE OR BETADINE) ON THE PROBE TIP WHEN THE LASER WAS ACTIVATED. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU) CAUTIONS THE USER TO "INSPECT THE PROBE FOOTPLATE FOR DEBRIS OR 'CHARRING' AND CONFIRM GEL IS ADEQUATELY PRESENT" AND IF A "BURN OCCURS, DISCONTINUE USE AND REPLACE THE DEVICE IMMEDIATELY." TYPICALLY, CONJUNCTIVAL BURNS RESOLVE WITHIN 24 TO 48 HOURS. THEREFORE, UNLESS EIT

  Patient problems: Eye Injury

  MAUDE report 24397187 ↗
• 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 15, 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 (MP3), THE PATIENT EXPERIENCED CONJUNCTIVAL BURN. THE PROBE, WHICH IS DISPOSABLE, WAS NOT RETURNED TO IRIDEX FOR FURTHER INVESTIGATION. CONJUNCTIVAL BURNS ARE A KNOWN POTENTIAL HARM ASSOCIATED WITH THE USE OF LASER DELIVERY IN OPHTHALMIC INDICATIONS. IT IS LISTED IN THE IFU INCLUDED IN MP3 DELIVERY DEVICE. NO INFORMATION REGARDING THE PATIENT, PATIENT RECOVERY, TREATMENT PARAMETERS USED WERE PROVIDED TO IRIDEX TO HAVE A CONCLUSIVE FINDING. IN ACCORDANCE WITH STANDARD PROTOCOL, IRIDEX WILL PROCEED WITH PROCESSING THE COMPLAINT BASED ON THE INFORMATION CURRENTLY AVAILABLE. ANOTHER FACTOR TO BE TAKEN INTO ACCOUNT FOR THE PATIENT INJURY REPORTED IS THAT OCCASIONALLY, THE TIP OF THE PROBE WILL BECOME CONTAMINATED WITH BLOOD OR TISSUE, AND THE CONTAMINANTS ON THE TIP CAN BECOME HATED WHEN EXPOSED TO LASER ENERGY. TYPICALLY, CONJUNCTIVAL BURNS RESOLVE WITHIN 24 TO 48 HOURS. THEREFORE, UNLESS EITHER MEDICAL INTERVENTION OR PERMANENT IMPAIRMENT ARE REPORTED, SCLERAL BURNS ARE NOT DEEMED A SERIOUS ADVERSE EVENT, BECAUSE CONJUNCTIVAL BURNS TYPICALLY: · DO NOT RESULT IN LIFE-THREATENING ILLNESS OR INJURY, · DO NOT RESULT IN PER

  Patient problems: Eye Injury

  MAUDE report 23804527 ↗
• InjuryDec 12, 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 (MP3), THE PATIENT EXPERIENCED CONJUNCTIVAL BURN. DURING TREATMENT THE PROBE WAS PRODUCING SMOKE AND BOILING SOUND, ALSO CONJUNCTIVA BURN SPOTS WERE SEEN. AFTERWARDS THE PROBE'S TIP TURNED BLACK AND HAD A BURNT SCENT. THE PROBE, WHICH IS DISPOSABLE, WAS NOT RETURNED TO IRIDEX FOR FURTHER INVESTIGATION. CONJUNCTIVAL BURNS ARE A KNOWN POTENTIAL HARM ASSOCIATED WITH THE USE OF LASER DELIVERY IN OPHTHALMIC INDICATIONS. IT IS LISTED IN BOTH THE IFU INCLUDED IN MP3 DELIVERY DEVICE. NO INFORMATION REGARDING THE PATIENT, PATIENT RECOVERY, TREATMENT PARAMETERS USED WERE PROVIDED TO IRIDEX TO HAVE A CONCLUSIVE FINDING. IN ACCORDANCE WITH STANDARD PROTOCOL, IRIDEX WILL PROCEED WITH PROCESSING THE COMPLAINT BASED ON THE INFORMATION CURRENTLY AVAILABLE. ANOTHER FACTOR TO BE TAKEN INTO ACCOUNT FOR THE PATIENT INJURY REPORTED IS THAT OCCASIONALLY, THE TIP OF THE PROBE WILL BECOME CONTAMINATED WITH BLOOD OR TISSUE, AND THE CONTAMINANTS ON THE TIP CAN BECOME HATED WHEN EXPOSED TO LASER ENERGY. TYPICALLY, CONJUNCTIVAL BURNS RESOLVE WITHIN 24 TO 48 HOURS. THEREFORE, UNLESS EITHER MEDICAL INTERVENTION OR PERMANENT IMPAIRMENT ARE REPORT

  Patient problems: Eye Injury

  MAUDE report 23791573 ↗
• InjuryDec 12, 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 (MP3), THE PATIENT EXPERIENCED CONJUNCTIVAL BURN. THE REPORTED SETTINGS USED FOR TREATMENT WERE CONSISTENT WITH THE MP3 IFU (2500 MW FOR 3.4 SECONDS WITH AN INTERVAL OF 20 SECONDS). NO PERMANENT IMPAIRMENT WAS REPORTED TO IRIDEX, AND NO MEDICAL INTERVENTION ASSOCIATED WITH THE BURN WAS REPORTED TO IRIDEX. THE PROBE, WHICH IS DISPOSABLE, WAS NOT RETURNED TO IRIDEX FOR FURTHER INVESTIGATION. CONJUNCTIVAL BURNS ARE A KNOWN POTENTIAL HARM ASSOCIATED WITH THE USE OF LASER DELIVERY IN OPHTHALMIC INDICATIONS. TYPICALLY, CONJUNCTIVAL BURNS RESOLVE WITHIN 24 TO 48 HOURS. THEREFORE, UNLESS EITHER MEDICAL INTERVENTION OR PERMANENT IMPAIRMENT ARE REPORTED, SCLERAL BURNS ARE NOT DEEMED A SERIOUS ADVERSE EVENT, BECAUSE CONJUNCTIVAL BURNS TYPICALLY: DO NOT RESULT IN LIFE-THREATENING ILLNESS OR INJURY, DO NOT RESULT IN PERMANENT IMPAIRMENT OF A BODY STRUCTURE OR A BODY FUNCTION, DO NOT REQUIRE HOSPITALIZATION OR PROLONGATION OF PATIENT HOSPITALIZATION, DO NOT REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PREVENT LIFE-THREATENING ILLNESS OR INJURY OR PERMANENT IMPAIRMENT TO A BODY STRUCTURE OR A BODY FUNCTION. THE LASER CONSOLE USED W

  Patient problems: Eye Injury

  MAUDE report 23791068 ↗
• 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 ↗
• InjuryDec 5, 2025Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings

  A PATIENT INCIDENT OCCURRED INVOLVING AN IRIDEX MICROPULSE P3 (MP3) RESULTING IN A CONJUNCTIVAL BURN. THE LASER CONSOLE USED WITH THE PROBE WAS IRIDEX CYCLO G6 LASER CONSOLE. DEVICE WAS NOT RETURNED FOR INVESTIGATION. CONJUNCTIVAL BURNS ARE A WELL-KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE MICROPULSE TREATMENT. IT IS LISTED IN BOTH THE IFU FOR THE MP3 DELIVERY DEVICE AS WELL AS IFU FOR THE CYCLO G6 LASER OPERATING MANUAL. THE SEVERITY OF THIS COMPLICATION IS CONSIDERED RELATIVELY LOW AND USUALLY RESOLVES WITHOUT INTERVENTION WITHIN 24-48 HOURS. THE POWER SETTING USED DURING THE TREATMENT WAS SET TO 2500MW WITH A TECHNIQUE OF A SINGLE 50 SEC SWEEP/QUADRANT. THE PRESSURE APPLIED WAS MODERATE. NO SUB-CONJUNCTIVAL HEMORRHAGE OR BLEEDING IN THE PRESENT SURGICAL FIELD WAS NOTED. THE EYE APPEARED TO BE VERY HYPEREMIC FROM YEARS OF USING GLAUCOMA DROPS. THERE WAS ALSO NOTED PIGMENTED LEGIONS PRESENT IN THE EYE AS WELL. THE TREATMENT PERFORMED DID NOT FULLY ALIGN WITH THE PARAMETERS RECOMMENDED IN THE MICROPULSE P3 PROBE IFU. WHILE THE POWER SETTING OF 2500 MW WAS WITHIN THE SUGGESTED RANGE AND LIKELY USED THE CORRECT DUTY CYCLE, THE TREATMENT TECHNIQUE DIFFERED FROM THE IFU GUIDANCE.

  Patient problems: Eye Injury

  MAUDE report 23735442 ↗
• InjuryDec 4, 2025Contamination; Contamination

  IT WAS REPORTED TO IRIDEX THAT WHILE USING THE MICROPULSE P3 PROBE, THE PHYSICIAN NOTICED SMOKE COMING OUT OF THE PROBE TIP. THERE WAS NO PATIENT HARM AT ALL FROM THIS INCIDENT. ALTHOUGH THERE WAS NO PATIENT HARM, BUT IF THE EVENT WERE TO RECUR AND THE SAME PROBE WERE USED TO TREAT A PATIENT IT COULD RESULT IN PATIENT HARM, I.E., CONJUNCTIVAL/SCLERAL BURN. AS A CONCLUSION, THIS EVENT IS DEEMED AS REPORTABLE TO THE FDA. DEVICE WAS NOT RETURNED TO IRIDEX FOR FURTHER INVESTIGATION. AS PER THE IFU, BEST PRACTICES TO BE CONSIDERED TO REDUCE THE OCCURRENCE OF CONJUNCTIVAL BURNS - 1. AVOID TREATING AREAS WITH CONJUNCTIVAL/SCLERAL PIGMENTATION, HYPEREMIA, HEMORRHAGE, MARKING INK, OR BETADINE, AS THESE CAN ABSORB 810 NM LIGHT AND INCREASE BURN RISK. 2. ALWAYS USE AND FREQUENTLY REAPPLY A VISCOUS, TRANSPARENT COUPLING AGENT TO ENSURE PROPER ENERGY TRANSFER AND REDUCE BURN RISK. 3. APPLY ONLY LIGHT CONTACT WITH THE PROBE; AVOID EXCESSIVE PRESSURE TO PREVENT TISSUE DAMAGE AND MINIMIZE BURN RISK. DURING THE INCIDENT, THE SETTINGS USED BY THE PHYSICIAN WERE A TOTAL OF 09 SWEEPS PER QUADRANT AND THE LASER POWER WAS SET AT 2200 MJ WITH A SWEEP VELOCITY OF 10 SECONDS. THE POWER AND SWEEP DURATION W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23723208 ↗

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