Alcon Grieshaber 339.21Recalls & reported problems
Alcon Laboratories, Inc. · Diathermy Probe DSP, 25G · Class 2
All models of Alcon Grieshaber (17)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Alcon Grieshaber diathermy probe is an ophthalmic probe used in eye surgery. Most of the 137 reports describe the probe not heating or not delivering electrocoagulation during procedures such as vitrectomy, with surgeons switching to another probe. The reports include no deaths and 2 injuries, and reports rose from 23 in the previous 12 months to 69 in the latest 12 months. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 142
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 142 adverse event reports that list this exact device (DI 07612717071377), received between Sep 8, 2021 and Sep 17, 2026 — classified as 2 injuries, 140 malfunctions.
The most frequently reported specific device problem is “Temperature Problem” (94 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 Problem94
- Insufficient Heating35
- Device-Device Incompatibility4
- Failure to Deliver Energy3
- Overheating of Device3
- Appropriate Device Problem Term/Code Not Available2
- Activation Problem1
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions96
- Insufficient Information47
- Hemorrhage/Blood Loss/Bleeding2
Recent adverse event reports
The 25 most recent of 142 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 17, 2026Temperature Problem
A physician reported that, during vitrectomy procedure, an ophthalmic diathermy probe would not be able to perform electrocoagulation. The surgery was completed on the same day after replacing the electrocoagulation head and patient impact has not been provided.
Patient problems: Insufficient Information
MAUDE report 50799861 ↗MalfunctionSep 14, 2026Temperature Problem
A physician reported that, prior to a vitrectomy surgery, an ophthalmic probe exhibited poor coagulation performance. The procedure was completed on the same day with an alternative product. without any patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50749679 ↗MalfunctionSep 14, 2026Device-Device Incompatibility
A nurse reported that, during a vitrectomy surgery, an ophthalmic probe could not be recognized after being connected to the machine. The procedure was completed on the same day. No patient harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50749613 ↗MalfunctionSep 11, 2026Temperature Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50738630 ↗MalfunctionSep 9, 2026Temperature Problem
A physician reported that, during a vitrectomy surgery, an ophthalmic probe was unable to perform electrocoagulation normally. The surgery was completed on the same day after replacing with another one. Information regarding patient impact has not been provided.
Patient problems: Insufficient Information
MAUDE report 50686485 ↗MalfunctionSep 4, 2026Temperature Problem
A physician reported that during vitrectomy surgery, an ophthalmic probe exhibited no electrocautery reaction. The surgery was completed on the same day with an alternative product and there was patient harm. Patient harm has not been provided. Additional information has been requested but is not available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50609478 ↗MalfunctionSep 3, 2026Temperature Problem
A physician reported that during vitrectomy surgery, an ophthalmic probe had no response after connected and unable to perform coagulation. The surgery was completed on the same day with new probe. Patient impact have not been provided.
Patient problems: Insufficient Information
MAUDE report 50582086 ↗MalfunctionSep 1, 2026Temperature Problem
A physician reported that, during vitrectomy surgery, an ophthalmic probe was unable to perform electrocoagulation. The surgery was completed on the same day using an alternative product with no patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50539409 ↗MalfunctionAug 30, 2026Temperature Problem
Patient problems: Insufficient Information
MAUDE report 50512278 ↗MalfunctionAug 28, 2026Temperature Problem
A physician reported that during calibration diathermy probe exhibited with no power. Procedure details and patient impact is unknown.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50499327 ↗MalfunctionAug 21, 2026Temperature Problem
A physician reported that during vitrectomy surgery, while using an ophthalmic probe, there was no electrocoagulation. The surgery was completed on the same day using an alternative product, and there was no patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50370971 ↗MalfunctionAug 21, 2026Temperature Problem
A government agency reported that during vitrectomy surgery an ophthalmic probe exhibited no electrocautery. The surgery was completed on the same day causing no impact on patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50370427 ↗MalfunctionAug 20, 2026Temperature Problem
A physician reported that an ophthalmic probe failed to electrocoagulate during a vitrectomy procedure. The surgery was successfully completed using a replacement probe. No patient impact was reported.
Patient problems: Insufficient Information
MAUDE report 50345169 ↗MalfunctionAug 7, 2026Temperature Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50174273 ↗MalfunctionJul 31, 2026Temperature Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50099184 ↗MalfunctionJun 26, 2026Temperature Problem
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING VITRECTOMY SURGERY, AN OPHTHALMIC PROBE HAS NOT COAGULATED. THE SURGERY YWAS COMPLETED ON THE SAME DAY. THE PATIENT IMPACT HAVE NOT BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 25635417 ↗MalfunctionJun 19, 2026Temperature Problem
A HEALTH CARE PROFESSIONAL REPORTED THAT AN OPHTHALMIC PROBE ELECTROCAUTERY WAS NOT EFFECTIVE BEFORE VITRECTOMY SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25563407 ↗MalfunctionJun 15, 2026Temperature Problem
A NURSE REPORTED THAT AN OPHTHALMIC PROBE DID NOT ELECTROCOAGULATE PRIOR TO VITRECTOMY SURGERY. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. NO PATIENT IMPACT WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25503113 ↗MalfunctionJun 10, 2026Temperature Problem
A NURSE REPORTED THAT NO REACTION FROM OPHTHALMIC PROBE DURING THE VITRECTOMY SURGERY. SURGERY HAS BEEN COMPLETED ON THE SAME DAY BY USING THE ALTERNATIVE PROBE. THERE WAS NO FURTHER PATIENT IMPACT WAS REPORTED.
Patient problems: Insufficient Information
MAUDE report 25459313 ↗MalfunctionJun 10, 2026Temperature Problem
A PHYSICIAN REPORTED THAT BEFORE PARS PLANA VITRECTOMY SURGERY, AN OPHTHALMIC ELECTROCOAGULATION HEAD COULD NOT PERFORM ELECTROCOAGULATION NORMALLY. THE PROCEDURE WAS COMPLETED ON THE SAME DAY AFTER REPLACING IT WITH ANOTHER DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25456439 ↗MalfunctionMay 4, 2026Temperature Problem
THE CUSTOMER REPORTED THAT BEFORE VITRECTOMY SURGERY ELECTROCOAGULATION OF OPHTHALMIC DIATHERMY PROBE WAS INEFFECTIVE. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25068081 ↗MalfunctionMay 4, 2026Temperature Problem
A PHYSICIAN REPORTED THAT OPHTHALMIC PROBE DID NOT TURN ON DURING THE SURGERY. SURGERY HAS BEEN COMPLETED ON THE SAME DAY. PATIENT IMPACT HAS NOT BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 25066145 ↗MalfunctionApr 30, 2026Temperature Problem
A NURSE REPORTED THAT AN OPHTHALMIC COAGULATION PROBE WAS INEFFECTIVE BEFORE THE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH AN ALTERNATIVE PRODUCT WITHOUT ANY PATIENT IMPACT. THIS REPORT PERTAINS TO TWO OF THE TWO REPORTS RECEIVED FROM THE SAME FACILITY
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25042953 ↗MalfunctionApr 30, 2026Temperature Problem
A NURSE REPORTED THAT AN OPHTHALMIC COAGULATION PROBE WOULD NOT RESPOND BEFORE THE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED WITH THE ALTERNATIVE PRODUCT WITHOUT ANY PATIENT IMPACT. THIS REPORT PERTAINS TO ONE OF THE TWO REPORTS RECEIVED FROM THE SAME FACILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25042952 ↗MalfunctionApr 29, 2026Temperature Problem
A CUSTOMER REPORTED THAT DURING SURGERY AN OPHTHALMIC DIATHERMY PROBE BURNING PROBLEM OCCURRED. THE PROCEDURE DETAILS AND PATIENT IMPACT WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 25028026 ↗
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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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