G-Probe™ RFID Box of 6 15980Recalls & reported problems
Iridex Corporation · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 12
- Deaths reported
- 0
- Injuries reported
- 12
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00813125015237), received between Sep 21, 2018 and Jun 22, 2026 — classified as 12 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem5
- Insufficient Device Problem Information2
- Appropriate Device Problem Term/Code Not Available1
- Contamination /Decontamination Problem1
- Output above Specifications1
- Use of Device Problem1
- Use of Incorrect Control/Treatment Settings1
Patient problems
- Eye Injury8
- Eye Burn2
- Choroidal Hemorrhage1
- Choroidal effusion1
- Visual Impairment1
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
InjuryJun 22, 2026Use of Device Problem
IT WAS REPORTED TO IRIDEX THAT DURING TRANSSCLERAL CYCLOPHOTOCOAGULATION (CPC) WAS PERFORMED OVER THE SUPERIOR 180 DEGREES USING AN RFID G-PROBE WITH A CYCLO G6 LASER CONSOLE, THE PATIENT EXPERIENCED CONJUNCTIVAL AND SCLERAL BURNS. THE PHYSICIAN REPORTED THAT TREATMENT WAS INITIATED AT 1500 MW/4000 MS AND THE SETTINGS WERE REDUCED TO 500 MW/2000 MS BEFORE BURNING STOPPED. APPROXIMATELY 15 SHOTS WERE DELIVERED USING A SINGLE-SHOT TECHNIQUE. THE MOST LIKELY CAUSE IS SUSPECTED TO BE SUBOPTIMAL LASER ENERGY TRANSMISSION AT THE PROBE/TISSUE INTERFACE, POTENTIALLY ASSOCIATED WITH INADEQUATE VISCOUS COUPLING AGENT USE AND/OR CONTINUED USE OF THE SAME PROBE AFTER BURNING WAS OBSERVED, RESULTING IN ENERGY CONCENTRATION AT THE OCULAR SURFACE RATHER THAN TRANSMISSION TO THE TARGETED CILIARY BODY TISSUE. NO PERMANENT VISION IMPAIRMENT, HOSPITALIZATION, OR MEDICAL/SURGICAL INTERVENTION RELATED TO THE BURNS WAS REPORTED. FOLLOW-UP COMMUNICATION INDICATED THE PATIENT DID WELL POSTOPERATIVELY WITH NO SIGNIFICANT ADVERSE CONDITIONS RELATED TO THE BURNS; HOWEVER, MINIMAL IOP REDUCTION WAS OBSERVED POST-PROCEDURE, WHICH IS CONSISTENT WITH THE POSSIBILITY THAT A SUBSTANTIAL PORTION OF THE DELIVERED EN
Patient problems: Eye Injury
MAUDE report 25587696 ↗InjuryApr 24, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED TO IRIDEX THAT WHILE USING THE G-PROBE RFID LASER DELIVERY DEVICE, THE PATIENT EXPERIENCED CONJUNCTIVAL BURN. NO PERMANENT IMPAIRMENT WAS REPORTED TO IRIDEX, AND NO MEDICAL INTERVENTION ASSOCIATED WITH THE BURN WAS REPORTED TO IRIDEX. REPLACEMENT G-PROBES ARE BEING SENT TO THE CUSTOMER. THE DEFECTIVE PROBE IS NOT AVAILABLE AT THE CUSTOMER AND WON'T BE RETURNED TO IRIDEX. ADDITIONALLY, IT SHOULD BE NOTED THAT 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. NO ISSUES REGARDING THE LASER CONSOLE BEING USED DURING THE TREATMENT WERE REPORTED TO IRIDEX. THE REPORTED SETTINGS USED FOR TREATMENT WERE CONSISTENT WITH THE IFU (40-SECOND PASSES PER HEMISPHERE; POWER: 1250 MV). NO PERMANENT IMPAIRMENT WAS REPORTED TO IRIDEX, AND NO MEDICAL INTERVENTION ASSOCIATED WITH THE BURN WAS REPORTED TO IRIDEX. AS PER THE IFU, FOLLOWING ARE THE RECOMMENDATIONS FOR TREATMENT PURPOSE - "KEEP THE G-PROBE TIP CLEAN TO MINIMIZE THE RISK OF BURNS TO THE OCULAR SURFACE. IF THE TIP BECOMES DIRTY DURING THE PROCEDURE, CLEAN IT GENTLY WITH AN ALCOHOL SWAB. IF A SCLERAL BURN OCCURS,
Patient problems: Eye Injury
MAUDE report 24987270 ↗InjuryDec 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED TO IRIDEX THAT A CONJUNCTIVAL TEAR OCCURRED WHILE TREATING A PATIENT BUT THE TEAR WAS MINOR AND IT HAPPENED AT THE END OF THE TREATMENT. THIS IS A PREDICTED COMPLICATION ASSOCIATED WITH THE USE OF ANY OPHTHALMIC LASER SYSTEM WHEN USED TO DELIVER TREATMENT. 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. TAKING A PROACTIVE APPROACH, IRIDEX REVIEWED IFU GUIDANCE FOR SCENARIOS WHERE THE G-PROBE MIGHT CONTRIBUTE TO CONJUNCTIVAL TEARING. THE IFU ADVISES: 1. KEEP THE PROBE TIP AND EYE SURFACE MOIST THROUGHOUT THE PROCEDURE. 2. IF THE DEVICE SNAGS ON THE CONJUNCTIVA, MOMENTARILY STOP LASER TREATMENT, RELEASE THE CONJUNCTIVA, REPOSITION THE DEVICE, AND THEN RESUME TREATMENT. TYPICALLY, CONJUNCTIVAL TEARS 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 IN
Patient problems: Eye Injury
MAUDE report 23891131 ↗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 G-PROBE RFID, THE PATIENT EXPERIENCED 2 SMALL BURN SPOTS AT LIMBUS POST PROCEDURE AND WAS GIVEN LIDO GEL FOR TREATMENT. NO OTHER INJURIES REPORTED. TREATMENT AND POWER SETTINGS NOT PROVIDED. THE G-PROBE WAS DISCARDED THE PROBE AND CONTINUED TREATMENT WITH A DIFFERENT G-PROBE WITHOUT ANY FAILURES DETECTED. 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
Patient problems: Eye Injury
MAUDE report 23809700 ↗InjuryDec 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PATIENT UNDERWENT LASER CYCLOPHOTOCOAGULATION USING THE G-PROBE WITH THE CYCLO G6 CONSOLE FOR THE MANAGEMENT OF MEDICALLY REFRACTORY GLAUCOMA. FOLLOWING THE PROCEDURE, THE PATIENT DEVELOPED CHOROIDAL EFFUSIONS. THE PATIENT HAD NO HISTORY OF ANTICOAGULANT USE, DIABETES, OR OTHER SYSTEMIC DISEASE. POSTOPERATIVELY, THE PATIENT DEVELOPED CHOROIDAL EFFUSIONS AND HYPOTONY, WITH A DECLINE IN VISION. NO CONJUNCTIVAL HEMORRHAGE, BLEEDING, PIGMENTED LESIONS, OR DARK AREAS WERE NOTED DURING OR AFTER THE PROCEDURE. NO DEVICE MALFUNCTIONS WERE NOTED DURING THE PROCEDURE. THE DEVICE WAS RETURNED FOR SERVICING BUT NO ISSUES WERE FOUND. THE TREATMENT PARAMETERS USED WERE CONSISTENT WITH THE G-PROBE IFU RECOMMENDATIONS: POWER OF 1500 MW, DURATION OF 3500 MS PER APPLICATION, AND A TOTAL OF 15 TREATMENT SPOTS. THE DEVICE FUNCTIONED AS INTENDED THROUGHOUT THE PROCEDURE, AND NO ALARMS OR MALFUNCTIONS WERE REPORTED. THE EVENT IS NOT DEVICE RELATED, THERE WAS NO DEVICE MALFUNCTION REPORTED. HYPOTONY WITH EFFUSIONS AND HEMORRHAGE AFTER G-PROBE CASES CAN HAPPEN WITH DISEASED EYES THAT ARE AT THE END OF THEIR TREATMENT PARADIGM. IT IS MOST LIKELY THAT THE CHOROIDAL EFFUSIONS ARE DUE TO A COMBINATION OF TH
Patient problems: Choroidal effusion
MAUDE report 23783250 ↗InjuryDec 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PATIENT UNDERWENT LASER CYCLOPHOTOCOAGULATION USING THE G-PROBE WITH THE CYCLO G6 CONSOLE FOR THE MANAGEMENT OF MEDICALLY REFRACTORY GLAUCOMA. FOLLOWING THE PROCEDURE, THE PATIENT DEVELOPED CHOROIDAL EFFUSIONS THAT WERE SUBSEQUENTLY COMPLICATED BY A SUPRACHOROIDAL HEMORRHAGE. THE TREATING PHYSICIAN REPORTED THAT THE PATIENT WAS ON DUAL ANTITHROMBOTIC THERAPY, WHICH SIGNIFICANTLY INCREASES THE RISK OF OCULAR HEMORRHAGIC COMPLICATIONS. NO DEVICE MALFUNCTIONS WERE NOTED DURING THE PROCEDURE. THE DEVICE WAS RETURNED FOR SERVICING BUT NO ISSUES WERE FOUND. THE PHYSICIAN SELECTED LASER TREATMENT AS A LESS INVASIVE ALTERNATIVE TO INCISIONAL SURGERY, GIVEN THE ELEVATED BLEEDING RISK ASSOCIATED WITH THE PATIENT'S ANTICOAGULATION STATUS. THE TREATMENT PARAMETERS USED DURING THE PROCEDURE DIFFERED SLIGHTLY FROM THE INSTRUCTIONS FOR USE (IFU) RECOMMENDATIONS. THE IFU SUGGESTS A POWER SETTING OF 1500 MW WITH A DURATION OF 3500 MS PER APPLICATION AND APPROXIMATELY 18-21 TREATMENT SPOTS OVER 270 DEGREES OF THE CILIARY BODY. IN THIS CASE, THE PHYSICIAN INITIATED TREATMENT AT 1500 MW AND TITRATED POWER UPWARD IN 5 MW INCREMENTS PER SPOT, REACHING A MAXIMUM OF 2000 MW. THE DURATION PER APPLICATION
Patient problems: Choroidal Hemorrhage
MAUDE report 23783065 ↗InjuryDec 2, 2025Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings
IRIDEX BECAME AWARE OF A PATIENT INCIDENT DURING A MEDICAL PROCEDURE RESULTING IN A CONJUNCTIVAL BURN. THE PROCEDURE WAS PERFORMED USING IRIDEX G-PROBE AND IRIDEX CYCLO G6 LASER CONSOLE. THE REPORTED PROCEDURE EMPLOYED HIGHER POWER SETTINGS: 2500 MW WITH 1000 MS PER SWEEP WITH 5 SWEEPS PER QUADRANT WHICH INDICATES A DEVIATION FROM THE IFU RECOMMENDED "SLOW COAGULATION" TECHNIQUE. THE IFU SUGGESTS USING LOWER POWER (1250 - 1500 MW) AND LONGER DURATION (3500 - 4000 MS) TO DELIVER CONTROLLED ENERGY OF APPROXIMATELY 5 JOULES PER APPLICATION. SINCE THE PARAMETERS USED ARE OUT OF SPECIFICATION, IT POTENTIALLY RESULTED IN INCREASING THE RISK OF TISSUE DAMAGE AND CONJUNCTIVAL BURN. THIS DEVIATION FROM RECOMMENDED PARAMETERS, COMBINED WITH POSSIBLE PROBE CONTAMINATION, MAY HAVE CONTRIBUTED TO THE ADVERSE OUTCOME. PROBE WAS DISCARDED POST PROCEDURE. THERE WERE NO OTHER COMPLICATIONS OR INJURIES REPORTED. NO PROBLEMS WITH THE LASER CONSOLE WAS REPORTED. CONJUNCTIVAL BURN IS A KNOWN POTENTIAL ISSUE WITH THE DELIVERY OF LASER ENERGY. THERE WAS NO REPORT OF ANY PERMANENT IMPAIRMENT TO THE PATIENT, AND CONJUNCTIVAL BURNS TYPICALLY: DO NOT RESULT IN LIFE-THREATENING ILLNESS OR INJURY, DO NOT RESUL
Patient problems: Eye Injury
MAUDE report 23699043 ↗InjuryNov 19, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED TO IRIDEX THAT WHILE USING THE G-PROBE RFID, THE PATIENT EXPERIENCED SCLERAL BURN. THE REPORTED SETTINGS USED FOR TREATMENT WERE CONSISTENT WITH THE G-PROBE IFU (1500 MW FOR 3.5 SECONDS). DURING THE PROCEDURE, BURNS WERE OBSERVED, THE POWER WAS THEN DECREASED TO 1400 MW, 1300 MW WITH SCLERAL BURNS, AND THE PROBE WAS INSPECTED AND DEBRIS WERE NOT OBSERVED. NO PERMANENT IMPAIRMENT WAS REPORTED TO IRIDEX, AND NO MEDICAL INTERVENTION ASSOCIATED WITH THE BURN WAS REPORTED TO IRIDEX. THE PROBE IS DISPOSABLE AND WAS NOT RETURNED TO IRIDEX FOR FURTHER INVESTIGATION. SCLERAL BURNS ARE A KNOWN POTENTIAL HARM ASSOCIATED WITH THE USE OF LASER DELIVERY IN OPHTHALMIC INDICATIONS. TYPICALLY, SCLERAL 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 SCLERAL 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
Patient problems: Eye Injury
MAUDE report 23597920 ↗InjuryNov 18, 2025Output above Specifications; Output above Specifications
IRIDEX BECAME AWARE OF THIS INCIDENT THROUGH PUBLISHED SCIENTIFIC LITERATURE. TRANSSCLERAL CYCLOPHOTOCOAGULATION (TCP) WAS PERFORMED USING AN IRIDEX G-PROBE DELIVERY DEVICE WITH THE IRIDEX CYCLO G6 LASER CONSOLE. DURING TREATMENT, CONJUNCTIVAL BURNS AND SCLERAL PERFORATION OCCURRED LEADING TO TERMINATION OF THE PROCEDURE. MEDICAL INTERVENTION WAS REQUIRED TO ADDRESS THE SCLERAL PERFORATION AND INCLUDED A PATCH GRAFT USING SPLIT-THICKNESS DONOR CORNEA. BECAUSE THERE WAS NO REPORT OF PROBE OR LASER CONSOLE MALFUNCTION, THE LASER SETTINGS (NUMBER OF APPLICATIONS AND TREATMENT PARAMETERS) WERE REVIEWED TO DETERMINE IF THE EVENT WAS RELATED TO LASER SETTINGS: · NUMBER OF APPLICATIONS: 9 TREATMENT SPOTS WERE APPLIED BEFORE THE PERFORATION OCCURRED (INITIAL AT 2100 MW, FIVE SPOTS AT 2050 MW, THEN THREE SPOTS AT 1500 MW). · TREATMENT PARAMETERS: ALL APPLICATIONS WERE PERFORMED AT 4-SECOND DURATION WITH POWER LEVELS UP TO 2050 MW. THE USER APPLIED AT LEAST 30% MORE LASER ENERGY THAN THE IRIDEX RECOMMENDED TREATMENT PARAMETERS GIVEN THE DURATION USED. THE IRIDEX RECOMMENDED TREATMENT PARAMETERS ARE: 1. FOR DARK BROWN EYES: 1250 MW FOR 4 SECONDS. 2. FOR ALL OTHER EYES: 1500 MW FOR 3.5 SECONDS
Patient problems: Eye Injury
MAUDE report 23589336 ↗InjuryJun 12, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem
A 55 YEAR MALE PATIENT WITH A KNOWN HISTORY OF MODERATE PRIMARY OPEN ANGLE GLAUCOMA EXPERIENCED TWO CONJUNCTIVAL BURNS IN THE RIGHT EYE DURING TREATMENT WITH THE CYCLO G6 LASER CONSOLE AND THE G-PROBE DELIVERY DEVICE. AS REPORTED BY THE COMPLAINANT, " ON STRARTING THE TREATMENT,PATIENT OBSERVED TO HAVE CONJUNCTIVAL BURNS. PROBE WAS INSPECTED AND OBSERVED TO BE SMOKING, EVEN AT 1600 MW. PROBE DISCONTINUED. NEW PROBE CONNECTED. TREATMENT COMPLETED WITH NEW PROBE." A RETROBULBAR BLOCK ANESTHETIC WAS APPLIED DURING THE PROCEDURE, NO VASCONSTRICTOR, LIQUID COUPLING AGENT OR BETADINE SOLUTION WAS USED. THERE WAS NO SUBCONJUNCTIVAL HEMORRHAGE OR BLEEDING PRESENT IN THE SURGICAL FIELD DURING TREATMENT. IT IS UNKNOWN IF THE USER OBSERVED ANY PIGMENTED LEGIONS OR DARK AREAS IN THE SURGICAL FIELD. THE PATIENT IS RECOVERING WELL AND DID NOT REQUIRE ANY FURTHER MANAGMENT.
Patient problems: Eye Burn; Eye Injury
MAUDE report 19525238 ↗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 E: UPDATES TO THE INITIAL REPORTER SECTION WITH INFROMATION REGARDING THE COMPLAINANT. 5) 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 CONJUNCTIVAL DURING TREATMENT WITH A CYCLO G6 LASER SYSTEM IN COMBINATION WITH THE G-PROBE AT THE LOWEST POWER SETTING. 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 16818110 ↗InjurySep 21, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
NURSE FOR A CONTINUOUS WAVE (CW) PROCEDURE AND PLUGGED IN A G-PROBE DELIVERY DEVICE; THE PROCEDURE WAS INTENDED TO BE PERFORMED IN MICROPULSE MODE. THE PHYSICIAN ACCEPTED THE G-PROBE FROM THE NURSE AND TREATED THE PATIENTS. THE CYCLO G6 CONSOLE SETTINGS WERE: 2000MW / 2000MS / 250 INTERVAL. THE PHYSICIAN DID NOTICE A DIFFERENCE IN DELIVERY DEVICE (MP3 PROBE COMPARED TO A G-PROBE) AND DECIDED TO PROCEED WITH THE PROCEDURE. WHILE THE TREATING PHYSICIAN WAS SWEEPING THE SUPERIOR ASPECT OF THE EYE, IN CONTINUOUS WAVE MODE, HE BEGAN TO SEE CONJUNCTIVAL SHRINKAGE AND SCLERAL BURNS OCCUR. HE TREATED FOR A DURATION OF 50 SECONDS TOTAL OVER MANY SPOTS DESPITE NOTING COMPLICATIONS CONTINUED TO TREAT THE INFERIOR ASPECT OF THE EYE IN THE SAME MANNER. AFTER THE PROCEDURE WAS COMPLETED, AND THE PHYSICIAN QUESTIONED THE NURSE AND REALIZED THE DELIVERY DEVICES WERE USED IN ERROR. AT FOLLOW-UP ON (B)(6) 2018, PATIENT WAS DOING WELL HAD AN INTRA-OCULAR PRESSURE (IOP) OF 14MMHG AND A LARGE SUB-CONJUNCTIVAL HEMORRHAGE PRESENT AT EXAMINATION IN THE SUPERIOR ASPECT. THE TREATING PHYSICIAN WAS UNABLE TO VISUALIZE THE SCLERA. THE INFERIOR ASPECT OF THE EYE WAS WITHIN NORMAL LIMITS. THE PATIENT HAD A FAIR
Patient problems: Visual Impairment
MAUDE report 7900087 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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