Grieshaber 27+ Alcon 339.31Recalls & reported problems
Alcon Laboratories, Inc. · 27+ Diathermy Probe, DSP · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 19
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 07612717071384), received between Jul 13, 2021 and Sep 25, 2026 — classified as 19 malfunctions.
The most frequently reported specific device problem is “Temperature Problem” (7 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
- Temperature Problem7
- Insufficient Heating6
- Accessory Incompatible1
- Appropriate Device Problem Term/Code Not Available1
- Break1
- Coagulation in Device or Device Ingredient1
- Device-Device Incompatibility1
- Electrical Power Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions18
- Insufficient Information1
Recent adverse event reports
The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Temperature Problem
A healthcare professional reported that an ophthalmic probe tip exhibited no energy output and was unable to coagulate during vitrectomy surgery. The surgery was completed on the same day using an alternate product, and there was no patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50895721 ↗MalfunctionJun 22, 2026Device-Device Incompatibility
A PHYSICIAN REPORTED THAT DURING SURGERY, THE OPHTHALMIC PROBE HAD A POOR CONNECTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED ON THE SAME DAY. PATIENT IMPACT HAS NOT BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 25577213 ↗MalfunctionDec 19, 2025Accessory Incompatible; Accessory Incompatible
A PHYSICIAN REPORTED THAT DURING SURGERY OPHTHALMIC PROBE CAME OFF WHEN TRIED TO USE. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH ALTERNATIVE PROBE AND THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23847784 ↗MalfunctionAug 6, 2025Temperature Problem; Temperature Problem
A HEALTH CARE PROFESSIONAL STATED THAT DURING VITRECTOMY SURGERY AN OPHTHALMIC PROBE THAT HAD AN ELECTROCOAGULATION HEAD COULD NOT BE USED FOR ELECTROCOAGULATION. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE NEW PROBE. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22724910 ↗MalfunctionJul 28, 2025Temperature Problem; Temperature Problem
A PHYSICIAN REPORTED THAT DURING VITRECTOMY SURGERY THE PROBE WAS NOT ENERGIZED. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22628629 ↗MalfunctionJul 25, 2025Temperature Problem; Temperature Problem
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING VITRECTOMY SURGERY AN OPHTHALMIC PROBE FAILED TO PERFORM ELECTROCAUTERY FUNCTION PROPERLY. THE SURGERY WAS COMPLETED ON SAME DAY AFTER REPLACING IT WITH A NEW ONE AND THERE IS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED, NONE HAS BEEN RECEIVED TILL DATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22610226 ↗MalfunctionJun 19, 2025Insufficient Heating; Insufficient Heating
A PHYSICIAN REPORTED THAT, BEFORE VITRECTOMY SURGERY, THE OPHTHALMIC DIATHERMY PROBE EMISSION COULD NOT BE PERFORMED BEFORE INSERTION. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH AN ALTERNATIVE PROBE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22292597 ↗MalfunctionMay 2, 2025Temperature Problem; Temperature Problem
A PHYSICIAN REPORTED THAT DURING VITRECTOMY SURGERY AN OPHTHALMIC DIATHERMY PROBE COULD NOT ELECTROCOAGULATE. THE SURGERY WAS COMPLETED AFTER A NEW REPLACEMENT WAS USED. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21948433 ↗MalfunctionFeb 11, 2025Temperature Problem; Temperature Problem
A NURSE REPORTED THAT THE OPHTHALMIC PROBE HAD A PROBLEM WITH THE ELECTROCOAGULATION HEAD, THERE WAS NO RESPONSE WHEN STEPPING DURING SURGERY. THE PROCEDURE WAS COMPLETED ON THE SAME DAY AFTER REPLACING IT WITH A NEW DIATHERMY PROBE. THERE WERE NO ABNORMALITIES IN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21355056 ↗MalfunctionSep 1, 2022Insufficient Heating; Insufficient Heating
A PHYSICIAN REPORTED THAT AN OPHTHALMIC DIATHERMY PROBE EXHIBITED INSUFFICIENT HEAT BEFORE SURGERY. THE SURGERY WAS PERFORMED AND COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15336387 ↗MalfunctionJun 10, 2022Break; Break
A PHYSICIAN REPORTED THAT AN OPHTHALMIC DIATHERMY PROBE HAD BROKEN TIP BEFORE A SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THE SURGERY WAS COMPLETED SUCCESSFULLY BY USING AN ALTERNATE PROBE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14654959 ↗MalfunctionApr 27, 2022Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient
A PHYSICIAN REPORTED THAT A DIATHERMY PROBE EXHIBITED NO ELECTROCOAGULATION FUNCTION BEFORE THE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER A NEW REPLACEMENT. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14216592 ↗MalfunctionJan 19, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
A NURSE REPORTED THAT DURING CALIBRATION A DIATHERMY PROBE DID NOT WORK. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13288215 ↗MalfunctionNov 13, 2021Temperature Problem; Temperature Problem
A NURSE REPORTED THAT AN OPHTHALMIC DIATHERMY PROBE DID NOT CAUTERIZE THE EYE TISSUE. THERE WAS NO REPORT OF ANY PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION HAS BEEN RECEIVED INDICATING THAT THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12808124 ↗MalfunctionSep 24, 2021Insufficient Heating; Insufficient Heating
A PHYSICIAN REPORTED A DIATHERMY TIP FAILED TO COAGULATE DURING SURGERY. AN ALTERNATE DIATHERMY PROBE WAS OBTAINED IN ORDER TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12527230 ↗MalfunctionSep 17, 2021Insufficient Heating; Insufficient Heating
A PHYSICIAN REPORTED THAT A DIATHERMY PROBE DID NOT WORK AFTER INSERTING INTO THE EYE DURING A CATARACT/VITRECTOMY COMBINATION SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER DIATHERMY PROBE. THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12491162 ↗MalfunctionSep 7, 2021Insufficient Heating; Insufficient Heating
A PHYSICIAN REPORT THAT PRIOR TO VITRECTOMY SURGERY, AN OPHTHALMIC DIATHERMY PROBE EXHIBITED NO DIATHERMY FUNCTION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12434604 ↗MalfunctionJul 14, 2021Insufficient Heating; Insufficient Heating
A PHYSICIAN REPORTED THAT A DIATHERMY PROBE COULD NOT CAUTERIZE THE EYE TISSUE DURING A CATARACT/VITRECTOMY COMBINATION PROCEDURE. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE INVOLVED EYE AND THE PATIENT IDENTIFIER ARE NOT AVAILABLE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12165527 ↗MalfunctionJul 13, 2021Electrical Power Problem; Electrical Power Problem
A PHYSICIAN REPORTED THAT DURING CATARACT/VITRECTOMY PROCEDURE THE ELECTRICITY DID NOT CONDUCT TO THE PROBE DURING INSERTION. THE SURGERY WAS COMPLETED AFTER REPLACING WITH THE ANOTHER PROBE. THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12160314 ↗
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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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