MicroPulse P3 Device Single 15522-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00813125016647), received between May 4, 2022 and Apr 21, 2026 — classified as 18 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, 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 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 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 ↗
• InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT INCIDENT OCCURRED INVOLVING AN IRIDEX MICROPULSE P3 (MP3) DEVICE THAT CAUSED SMOKING AND BUBBLING RESULTING IN A CONJUNCTIVAL BURN. THE LASER CONSOLE USED WITH THE PROBE WAS IRIDEX CYCLO G6 LASER CONSOLE. THE MP3 PROBE DISCARDED. THE CYCLO G6 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. DURING THE INCIDENT, THE SETTINGS USED BY THE PHYSICIAN WERE THAT EACH SWEEP LASTED ABOUT 15 SECONDS, WITH A TOTAL OF FIVE SWEEPS PER QUADRANT. LASER POWER WAS SET AT 2500 MW, AND THE DUTY CYCLE WAS MAINTAINED AT 31.3% (0.5 MS ON / 1.1 MS OFF). THESE SETTINGS FALL WITHIN THE IRIDEX IFU RECOMMENDED RANGE OF 2000-2500 MW, 10-20 SECONDS PER SWEEP, AND 3-5 PASSES PER QUADRANT, POSITIONING THE TREATMENT AT THE UPPER END OF THE RECOMMENDED SPECTRUM. AS PER THE IFU, BEST PRACTICES TO BE CONSIDERED TO REDUCE THE OCCURRENCE OF CONJUNCTIVAL BURNS - 1. AVOID TREATING AR

  Patient problems: Eye Injury

  MAUDE report 23707219 ↗
• MalfunctionAug 8, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IRIDEX BECAME AWARE OF A PATIENT INCIDENT THAT WAS REPORTED BY (B)(4) (DISTRIBUTOR) ON 03/17/2023. IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, A SURGEON SMELLED BURNING AND SAW SMOKE COMING OUT OF THE TIP OF THE PROBE. IT WAS SHOWN THAT THE TIP OF THE PROBE WAS BURNED AND MELTED AFTER PROCEDURE. THE DOCTOR STOPPED APPLYING THE LASER AS SOON AS THE PROBLEM BECAME EVIDENT. THE PATIENT HAD A MILD BURN ON THE CONJUNCTIVA POST PROCEDURE WITH NO OTHER INJURIES REPORTED. THE ISSUE OCCURRED USING A MICROPULSE P3 DEVICE ON A CYCLO G6 LASER CONSOLE. THE TREATMENT SETTING AND TECHNIQUE USED DURING THE PROCEDURE WAS SET TO 2500MW. THE EQUIPMENT CONNECTED TO AC WAS 110VAC AND PATIENT WAS TREATED FOR 90 SECONDS AT A HIGHER BASE AT 2500 MW, THEN TREATED AT A LOWER HEMISPHERE FOR 20 SECONDS OF SPEED EACH SWEEP (10SEC BY QUADRANT) AT 2500MW. DOCTOR WAS USING 2% METHYL CELLULOSE DURING THE CASE AND PER PROTOCOL, 2% METHYLCELLULOSE IS TO BE USED IN ALL MEDICAL PROCEDURES. IT WAS NOTED THAT THE DOCTOR IS VERY EXPERIENCED WITH CYCLO G6 AND WAS FOLLOWING PROTOCOL FOR ALL PATIENT PROCEDURES AND TREATMENT SETTINGS PER THE IRIDEX RECOMMENDATION. THE CYCLO G6 LASER CONSOLE OPERATOR MANUAL OPERATOR MAN

  Patient problems: Eye Injury

  MAUDE report 19940572 ↗
• InjuryJun 17, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO IRIDEX THAT A PATIENT EXPERIENCED A CONJUNCTIVAL BURN DURING TREATMENT WITH THE MICROPULSE P3 PROBE DELIVERY DEVICE. THE COMPLAINANT ALSO COMPLAINED THAT THE PROBE TURNED BLACK. NO FURTHER INFORMATION REGARDING THE REPORTED ADVERSE EVENT WAS GIVEN. IRIDEX IS CURRENTLY INVESTIGATING THE COMPLAINT AND ATTEMPTS TO CONTACT THE COMPLAINANT HAS BEEN MADE TO GATHER MORE INFORMATION.

  Patient problems: Eye Burn; Eye Injury

  MAUDE report 19548125 ↗
• InjuryJun 14, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  A FEMALE PATIENT WITH A KNOWN HISTORY OF CHRONIC ANGLE CLOSURE GLAUCOMA PRESENTED WITH CONJUNCTIVAL BURNS IN BOTH THE LEFT AND RIGHT EYE DURING TREATMENT WITH THE MICROPULSE P3 PROBE DELIVERY DEVICE. A PERIBULBAR ANESTHETIC WAS APPLIED TO BOTH EYES AND A LIQUID INTERFACE, SYSTANE GEL, WAS USED DURING THE PROCEDURE. THE FOLLOWING TREATMENT SETTINGS WERE USED ON THE PATIENT: POWER SETTINGS: 3000MW, SWEEP SPEED VELOCITY: ABOUT 180 DEGREE OVER 90 SECOND, NUMBER OF SWEEPS USED: 2X90 SECONDS WITH SOME OVERLAP. MODERATE PRESSURE WAS APPLIED DURING SWEEPING WITH THE PROBE WHILE TREATING THE EYES. THERE WERE NO OTHER COMPLICATIONS, SUCH AS SUB-CONJUNCTIVAL HEMORRHAGE OR BLOOD PRESENT ON THE SURGICAL FIELD, PIGMENTATION LESIONS OR DARK AREAS OF PIGMENTATION PRESENT IN THE SURGICAL FIELD. THE PATIENT WAS GIVEN TWO TUBES OF ANTIBIOTIC/STEROID OINTMENT ALONG WITH TAPES AND PATCHES TO DRESS THE EYE ON DISCHARGE. ON FOLLOW UP WITH THE PATIENT ON THE SECOND POST-OPERATIVE DAY, THE PATIENT WAS DOING WELL AND THE CONJUNCTIVA WAS HEALING SATISFACTORILY. THE INTRAOCULAR PRESSURE WAS REDUCED FROM THE PRE-LASER IN BOTH THE EYES.

  Patient problems: Eye Burn; Eye Injury

  MAUDE report 19539396 ↗
• InjuryJun 14, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  A PATIENT EXPERIENCED A SUBCONJUNCTIVAL HEMORRHAGE DURING TREATMENT WITH THE MICROPULSE P3 PROBE DELIVERY DEVICE. NO FURTHER INFORMATION REGARDING THIS ADVERSE EVENT IS AVAILABLE. THE ADVERSE EVENT IS BEING INVESTIGATED BY IRIDEX.

  Patient problems: Conjunctival Hemorrhage

  MAUDE report 19538669 ↗
• 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: 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 INFROMATION 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 MILD CONJUNCTIVAL DURING TREATMENT WITH A CYCLO G6 LASER SYSTEM IN COMBINATION WITH THE MICROPULSE P3 PROBE. THE TREATMENT SETTINGS USED WERE WITHIN THE RECOMMENDED SETTINGS. 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 INFORM

  Patient problems: Eye Burn

  MAUDE report 16820114 ↗
• InjuryNov 30, 2022Device Contamination with Chemical or Other Material; Appropriate Device Problem Term/Code Not Available; Device Contamination with Chemical or Other Material; Appropriate Device Problem Term/Code Not Available

  IRIDEX BECAME AWARE OF A PATIENT EXPERIENCING CONJUNCTIVAL BURN DURING TREATMENT USING A 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. IRIDEX WILL CONTINUE TO FOLLOW-UP WITH THE DOCTOR FOR INFORMATION REGARDING PATIENT RECOVERY.

  Patient problems: Eye Burn; Eye Injury

  MAUDE report 15885658 ↗
• InjuryNov 30, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IRIDEX BECAME AWARE OF A COMPLAINT REPORTING THE PRESENCE OF SMOKE 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 15885654 ↗
• InjuryNov 18, 2022Appropriate 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 15826067 ↗
• InjuryJun 20, 2022Output Problem

  IRIDEX BECAME AWARE OF A PATIENT EXPERIENCING CONJUNCTIVAL HEMORRHAGE DURING TREATMENT USING A MICROPULSE P3 PROBE AND CYCLO G6 LASER SYSTEM. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED, AND NO ADDITIONAL INFORMATION HAS BEEN PROVIDED BY THE CLINIC OR TREATING PHYSICIAN. HOWEVER, THE TREATING PHYSICIAN DID OBSERVE SOME DISCREPANCY WITH THE PROBE, REPLACED THE PROBE AND PERFORMED THE TREATMENT. THERE IS NO ADDITIONAL INFORMATION AVAILABLE CURRENTLY. ENGINEERING FAILURE ANALYSIS WAS NOT PERFORMED BECAUSE THE DEVICE WAS NOT RETURNED FOR EVALUATION. IF THE DEVICES ARE RETURNED AND THE RESULTS OF FAILURE ANALYSIS INDICATE NEW INFORMATION, THE ADVERSE EVENT REPORT WILL BE AMENDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14749438 ↗
• InjuryJun 7, 2022Adverse Event Without Identified Device or Use Problem

  IRIDEX BECAME AWARE OF A PATIENT EXPERIENCING CONJUNCTIVAL BURN DURING TREATMENT USING A MICROPULSE P3 PROBE AND CYCLO G6 LASER SYSTEM 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. HOWEVER, THE TREATING PHYSICIAN DID OBSERVE SOME TISSUE AT THE TIP OF THE DEVICE. BASED ON SIMILAR REPORTED EVENTS, THIS IS SUGGESTING THAT THERE MAY HAVE BEEN SOME TISSUE (E.G. BLOOD, TISSUE OR BETADINE) ON THE PROBE TIP WHEN THE LASER WAS ACTIVATED. IF THERE IS TISSUE, BLOOD OR OTHER MATTER ON THE TIP OF THE DEVICE WHEN THE LASER IS ACTIVATED, THIS MAY CREATE A CONDITION WHERE A BURN MAY OCCUR. THE OPERATOR MANUAL INSTRUCTS TO INSPECT THE TIP OF THE DEVICE AND REPLACE IF CONTAMINATION IS OBSERVED. ENGINEERING FAILURE ANALYSIS COULD NOT BE PERFORMED BECAUSE THE DEVICE WAS NOT RETURNED FOR EVALUATION. IRIDEX TEAM DID NOT RECEIVE ANY RESPONSE FROM THE DOCTOR FOR SEVERAL FOLLOW UP EMAILS. THE RESULTS OF POST MARKET DATA REVIEW INDICATE THAT THIS FAILURE MODE IS NOT OCCURRING WITH GREATER SEVERITY OR FREQUENCY BASED ON THE NU

  Patient problems: Eye Burn

  MAUDE report 14627225 ↗
• InjuryMay 4, 2022Use of Device Problem

  IRIDEX BECAME AWARE OF A COMPLAINT REPORTING THAT THE TIP OF THE PROBE BEGAN EMITTING SMOKE DURING THE PROCEDURE AND THAT THE PATIENT EXPERIENCED A CONJUNCTIVAL BURN. THE PROCEDURE WAS PERFORMED USING A MICROPULSE P3 PROBE AND CYCLO G6 LASER SYSTEM. A CONCLUSIVE ROOT CAUSE FOR THIS EVENT WAS NOT DETERMINED. ENGINEERING FAILURE ANALYSIS COULD NOT BE PERFORMED BECAUSE THE DEVICE WAS NOT RETURNED FOR EVALUATION. BASED ON THE INFORMATION PROVIDED BY THE TREATING PHYSICIAN, IT IS POSSIBLE THAT THE SUBSTITUTION OF AN ALTERNATIVE ANESTHETIC LUBRICATING GEL MAY HAVE CONTRIBUTED TO THIS EVENT. THE PHYSICIAN NOTED THAT SHE USED MORE GEL THAT USUAL AND SUSPECTED THIS MAY HAVE PLAYED A ROLE. THE MANUFACTURING DEVICE HISTORY RECORDS WERE REVIEWED, AND NO ANOMALIES OR ISSUES WERE IDENTIFIED. THE RESULTS OF POST MARKET DATA REVIEW SUGGEST 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 14277527 ↗