G-Probe™ RFID Single 15980-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00813125015220), received between Mar 20, 2022 and May 11, 2026 — classified as 15 injuries.

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 16, 2026.

Most reported problems

Recent adverse event reports

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

• InjuryMay 11, 2026Use of Device Problem

  IRIDEX RECEIVED AN ADVERSE EVENT REPORT VIA THE FDA MEDWATCH PROGRAM (REPORT NUMBER: MW5184223) OF A SCLERAL PERFORATION REQUIRING A SCLERAL PATCH GRAFT AS SURGICAL INTERVENTION. IN THE MEDWATCH REPORT, IT WAS REPORTED THAT THE AE OCCURRED WHEN THE PHYSICIAN WAS PERFORMING CONTINUOUS WAVE TRANSSCLERAL CYCLOPHOTOCOAGULATION (TSCPC) ON A PATIENT WITH SEVERE GLAUCOMA USING AN IRIDEX CYCLO G6 LASER SYSTEM IN CONJUNCTION WITH A G-PROBE RFID DELIVERY DEVICE. AS PER THE REPORT, THE PROCEDURE WAS CONDUCTED WITH COPIOUS AMOUNTS OF LUBRICATING GEL, AND CONSISTENT CONTACT BETWEEN THE PROBE AND THE OCULAR SURFACE WAS REPORTEDLY MAINTAINED THROUGHOUT TREATMENT. ALTHOUGH NOT STANDARD OPERATING PROCEDURE, THE PHYSICIAN PERFORMED A SECOND TREATMENT PASS, AND AT THE 14TH LASER APPLICATION SITE, A SCLERAL PERFORATION WAS OBSERVED. THE PROCEDURE WAS IMMEDIATELY DISCONTINUED AND THE PATIENT UNDERWENT A SCLERAL PATCH GRAFT AS A SURGICAL INTERVENTION. THE DELIVERY DEVICE IFU WARNS THE USER OF POTENTIAL CONTRIBUTORS TO SCLERAL BURNS RESULTING IN SCLERAL PERFORATION. THE POSSIBLE CONTRIBUTORS INCLUDE (1) EXCESSIVE POWER AND/OR ENERGY DELIVERED, (2) THE PRESENCE OF BLOOD AND/OR TISSUE BENEATH THE DELIVERY

  Patient problems: Eye Injury

  MAUDE report 25142872 ↗
• InjuryDec 23, 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 G-PROBE RFID, THREE PROBES BURNT WHILE TREATING PATIENT TODAY. THE STAFF MENTIONED THAT THEY USED BETADINE BUT NOT SURE IF THIS WAS THE CAUSE OF THE ISSUE. NO OTHER INJURIES REPORTED. TREATMENT AND POWER SETTINGS NOT PROVIDED. THE G-PROBE WAS 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

  Patient problems: Eye Injury

  MAUDE report 23883023 ↗
• InjuryDec 18, 2025Defective Component; Defective Component

  IRIDEX BECAME AWARE OF AN INCIDENT THAT DURING A CILIARY BODY PHOTOCOAGULATION PROCEDURE, THE PATIENT'S SCLERA COAGULATED WHEN USING THE G-PROBE DELIVERY DEVICE. THE TREATMENT WAS BEING PERFORMED ALONG WITH THE CYCLO G6 LASER CONSOLE. THE COMPLAINANT SPECIFICALLY MENTIONED THAT THE TIP OF THE G-PROBE WAS DIFFERENT FROM THAT OF THE NORMAL PRODUCT. A REPLACEMENT PROBE WAS USED, AND PROCEDURE WAS COMPLETED WITH NO FURTHER COMPLICATIONS. THIS EVENT IS A KNOWN FAILURE MODE BASED ON FUNCTIONAL DESIGN FEATURES AND MAY REQUIRE INTERVENTION.

  Patient problems: Eye Injury

  MAUDE report 23840279 ↗
• InjuryDec 2, 2025Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings

  IT WAS REPORTED TO IRIDEX THAT WHILE USING THE G-PROBE, THE PATIENT EXPERIENCED SCLERAL BURN. THE HOSPITAL NOTED THAT THE OUTPUT POWER APPEARED HIGHER THAN EXPECTED; HOWEVER, SUBSEQUENT POWER OUTPUT TESTING CONDUCTED BY THE HOSPITAL CONFIRMED THAT THE LASER POWER WAS WITHIN SPECIFICATION. NO PERMANENT IMPAIRMENT WAS REPORTED TO IRIDEX, AND NO MEDICAL INTERVENTION ASSOCIATED WITH THE BURN WAS REPORTED TO IRIDEX. THE PROBE (SINGLE USE AND DISPOSABLE) OR THE LASER CONSOLE WAS NOT RETURNED TO IRIDEX FOR FURTHER INVESTIGATION. SCLERAL BURNS ARE A KNOWN POTENTIAL HARM ASSOCIATED WITH THE USE OF LASER DELIVERY IN OPHTHALMIC DEVICE INDICATIONS. THE LASER CONSOLE USED WITH THE PROBE IS THE CYCLO G6 LASER CONSOLE. IRIDEX FURTHER ASSESSED THAT THE MOST LIKELY CAUSE OF THE BURNS WAS CONTAMINATION ON THE PROBE TIP (E.G., BLOOD, TISSUE, OR BETADINE), WHICH CAN HEAT THE PROBE AND CAUSE LOCALIZED BURNS. THE IFU CAUTIONS USERS TO INSPECT THE PROBE FOR DEBRIS AND DISCONTINUE USE IF BURNS OCCUR. BASED ON THIS ASSESSMENT, IRIDEX DID NOT IDENTIFY ANY PRODUCT SAFETY RISK. A REVIEW OF THE REPORTED TREATMENT PARAMETERS INDICATES A DEVIATION FROM THE IFU-RECOMMENDED "SLOW COAGULATION" TECHNIQUE. THE IFU SU

  Patient problems: Eye Injury

  MAUDE report 23697106 ↗
• InjuryNov 22, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IRIDEX BECAME AWARE OF A PATIENT EXPERIENCING CORNEAL DAMAGE POST TREATMENT WITH A G-PROBE. PART A IS NOT FILLED OUT AS PATIENT IDENTIFIER DETAILS WERE NOT PROVIDE TO IRIDEX. THE TREATMENT PARAMETERS WERE WITHIN SPECIFICATION. ENGINEERING FAILURE ANALYSIS COULD NOT BE PERFORMED BECAUSE THE DEVICE WAS NOT RETURNED FOR EVALUATION. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED, AND NO ADDITIONAL INFORMATION HAS BEEN PROVIDED BY THE CLINIC OR TREATING PHYSICIAN. IRIDEX WILL CONTINUE TO FOLLOW-UP WITH THE CLINIC.

  Patient problems: Eye Injury

  MAUDE report 18194881 ↗
• InjuryNov 10, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IRIDEX BECAME AWARE TWO PATIENTS EXPERIENCING SCLERAL BURNS POST TREATMENT WITH A MICROPULSE P3 PROBE. PART A IS NOT FILLED OUT AS PATIENT IDENTIFIER DETAILS WERE NOT PROVIDE TO IRIDEX. THE TREATMENT PARAMETERS WERE WITHIN SPECIFICATION AND THE TREATING PHYSICIAN ALSO REPORTED THAT LASER CONSOLE USED TO TREAT THE PATIENT WAS PRODUCING LOW POWER WHEN A POWER TEST WAS CONDUCTED. ENGINEERING FAILURE ANALYSIS COULD NOT BE PERFORMED BECAUSE THE DEVICE WAS NOT RETURNED FOR EVALUATION. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED, AND NO ADDITIONAL INFORMATION HAS BEEN PROVIDED BY THE CLINIC OR TREATING PHYSICIAN. IRIDEX WILL CONTINUE TO FOLLOW-UP WITH THE CLINIC.

  Patient problems: Eye Burn

  MAUDE report 18116350 ↗
• InjuryAug 24, 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: 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 INFORMATION 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 COMPLAINT REPORTING A MILD CONJUCTIVAL BURN USING A G-PROBE. THE PROBE WAS REPLACED AND THE TREATMENT WAS COMPLETED SUCCESSFULLY. 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 R

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17612850 ↗
• InjuryMay 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: 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 BURN MARKS DURING TREATMENT WITH THE G-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 RECOVERY.

  Patient problems: Eye Burn

  MAUDE report 16924107 ↗
• InjuryMay 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 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 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 AN INJURY DURING TREATMENT WITH THE G-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 RECOVERY.

  Patient problems: Eye Injury

  MAUDE report 16924079 ↗
• 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 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 COAGULATION DURING TREATMENT WITH THE G-PROBE. THE DOCTOR REPORTED THAT THE TIP OF THE PROBE WAS DIFFERENT AND MAY HAVE RESULTED IN THIS INCIDENT. 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

  Patient problems: Eye Burn

  MAUDE report 16820124 ↗
• InjuryDec 20, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IRIDEX BECAME AWARE OF A PATIENT EXPERIENCING AN INJURY DURING TREATMENT WITH A G PROBE DELIVERY DEVICE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED TO 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 Injury

  MAUDE report 16015628 ↗
• InjuryMay 27, 2022Contamination /Decontamination Problem

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

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14528297 ↗
• InjuryMay 4, 2022Adverse Event Without Identified Device or Use Problem

  IRIDEX BECAME AWARE OF A PATIENT EXPERIENCING CONJUNCTIVAL BURN DURING TREATMENT WITH A MICROPULSE P3 PROBE AND CYCLO G6 LASER SYSTEM. BASED ON THE INFORMATION PROVIDED, IT APPEARS THE TREATMENT WAS PERFORMED WITHIN SPECIFICATIONS. ENGINEERING FAILURE ANALYSIS COULD NOT BE PERFORMED BECAUSE THE DEVICE WAS NOT RETURNED FOR EVALUATION. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED, AND NO ADDITIONAL INFORMATION HAS BEEN PROVIDED BY THE CLINIC OR TREATING PHYSICIAN. IRIDEX MADE ATTEMPTS TO FOLLOW UP AND GATHER ADDITIONAL INFORMATION BUT ALL ATTEMPTS WERE UNSUCCESSFUL. 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 14277759 ↗
• 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. THE PROCEDURE WAS PERFORMED USING A MICROPULSE P3 PROBE AND CYCLO G6 LASER SYSTEM. IT WAS NOTED BEFORE THE PROCEDURE THAT PATIENT HAD LIGHTLY PIGMENTED CONJUNCTIVA. PIGMENTED CONJUNCTIVA PRESENTS A KNOWN PROCEDURAL RISK BECAUSE THE PIGMENTED TISSUE CAN ABSORB THE LASER ENERGY AND INCREASE THE CHANCE OF A TISSUE BURN OCCURRING. IN THIS CASE, THE DOCTOR REPORTED THAT SMOKE WAS OBSERVED COMING FROM THE TIP OF THE DEVICE AT THE BEGINNING OF TREATMENT. THE DOCTOR ABORTED THE PROCEDURE AFTER THIS OBSERVATION. A CONJUNCTIVAL BURN WAS OBSERVED, AND THE DOCTOR PERFORMED TREATMENT FOR THE BURN. THE MOST LIKELY CAUSE OF THIS EVENT IS THE ACTIVATION OF THE LASER OVER THE AREAS PIGMENTED CONJUNCTIVA. AFTER ACTIVATION, SOME TISSUE WAS TRANSFERRED TO THE DEVICE TIP AND THE LASER WAS ACTIVATED AGAIN RESULTING IN THE "SMOKING TIP". THE IFU PROVIDES INSTRUCTIONS TO THE USER TO EXAMINE THE TIP OF THE DEVICE TO MAKE SURE NO BLOOD OR OTHER CONTAMINANTS ARE PRESENT. PER THE IFU CONTAMINATION OF THE FIBER OPTIC TIP BY BLOOD OR TISSUE CHAR MAY RESULT IN OCULAR SURFACE BURNS. HEAVY PERILIMBAL C

  Patient problems: Eye Burn

  MAUDE report 14277485 ↗
• InjuryMar 20, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IRIDEX BECAME AWARE OF A COMPLAINT REPORTING A PATIENT EXPERIENCING CONJUNCTIVAL BURN DURING TREATMENT WITH THE CYCLO G6 LASER SYSTEM IN COMBINATION WITH G-PROBE. THE TREATMENT WAS PERFORMED WITHIN SPECIFICATIONS. ENGINEERING FAILURE ANALYSIS WAS PERFORMED ON THE RETURNED LASER SYSTEM. THE INVESTIGATION AND TESTING DID NOT REPLICATE A POWER SURGE. IT WAS OBSERVED THAT THE POWER VALUES WERE BELOW SPECIFICATION. THE LOW POWER CONDITION DOES NOT APPEAR TO BE A CONTRIBUTING FACTOR FOR THIS INCIDENT. IRIDEX HAS REQUESTED THE CLINIC TO RETURN THE G-PROBE ASSOCIATED USED DURING TREATMENT. A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED AT THIS POINT AND ADDITIONAL INVESTIGATION WILL BE PERFORMED IF THE PROBE IS RETURNED.

  Patient problems: Eye Burn

  MAUDE report 13830911 ↗