Alcon GrieshaberRecalls & reported problems across all models
Alcon Laboratories, Inc. · 17 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 253
- Deaths reported
- 0
- Injuries reported
- 31
- Recalls
- 0
We found 17 models of Alcon Grieshaber by Alcon Laboratories, Inc. in the FDA's device registry (GUDID). Together they are named in 253 adverse event reports in the FDA's MAUDE database, received between Mar 22, 2021 and Sep 24, 2026 — classified as 31 injuries, 222 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Alcon Grieshaber problems
Device problems
- Temperature Problem94
- Insufficient Heating35
- Adverse Event Without Identified Device or Use Problem28
- Improper Flow or Infusion19
- Break14
- Suction Failure10
- Difficult to Open or Close8
- Appropriate Device Problem Term/Code Not Available7
Patient problems
- No Clinical Signs, Symptoms or Conditions165
- Insufficient Information64
- Retinal Detachment11
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available10
- Retinal Tear9
- Hemorrhage/Blood Loss/Bleeding7
- Inflammation3
- Visual Impairment3
Alcon Grieshaber models
17 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Alcon Grieshaber 339.21Unit, Phacofragmentation142 reports
- Alcon Grieshaber 337.84Cannula, Ophthalmic37 reports
- Alcon Grieshaber 712.00.11Forceps, ophthalmic11 reports
- Alcon Grieshaber 618.60Lens, fundus, hruby, diagnostic11 reports
- Alcon Grieshaber 725.03Unit, Phacofragmentation9 reports
- Alcon Grieshaber 337.86Cannula, Ophthalmic7 reports
- Alcon Grieshaber 723.52SCISSORS, OPHTHALMIC6 reports
- Alcon Grieshaber 725.52SCISSORS, OPHTHALMIC6 reports
- Alcon Grieshaber 681.05Knife, ophthalmic5 reports
- Alcon Grieshaber 725.44Forceps, ophthalmic5 reports
- Alcon Grieshaber 611.74Clip, iris retractor4 reports
- Alcon Grieshaber 701.11Unit, Phacofragmentation3 reports
- Alcon Grieshaber 337.92Hook, ophthalmic2 reports
- Alcon Grieshaber 723.44Forceps, ophthalmic2 reports
- Alcon Grieshaber 611.75Clip, iris retractor1 report
- Alcon Grieshaber 720.52SCISSORS, OPHTHALMIC1 report
- Alcon Grieshaber 723.45Forceps, ophthalmic1 report
Recent Alcon Grieshaber adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Improper Flow or Infusion
A physician reported that during test, an ophthalmic tip could not perform aspiration. Details of procedure was not 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 50881103 ↗MalfunctionSep 22, 2026Improper Flow or Infusion
A physician reported that, during a vitrectomy procedure, the ophthalmic backflush tubing was blocked and unable to provide normal suction. The procedure was completed on the same day after replacing the backflush. Patient impact 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 50851514 ↗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 15, 2026Improper Flow or Infusion
The physician reported that during vitrectomy surgery, an ophthalmic device tube was blocked and cannot aspirate normally. The surgery was completed on the same day with alternative product. There was no further patient impact was reported, Additional information has been requested, but none received to date.
Patient problems: Insufficient Information
MAUDE report 50774187 ↗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 12, 2026Improper Flow or Infusion
Patient problems: Insufficient Information
MAUDE report 50745345 ↗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 ↗
Other Alcon Laboratories, Inc. products
- Clareon1,142 models · 8,100 reports · 1 recall
- Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT8 models · 2,968 reports · 5 recalls
- Constellation13 models · 2,176 reports · 4 recalls
- CONSTELLATION HYPERVIT TOTAL PLUS5 models · 2,098 reports · 4 recalls
- Centurion5 models · 1,967 reports
- ACRYSOF353 models · 1,890 reports
- AcrySof UltraSert102 models · 1,467 reports · 1 recall
- MONARCH III2 models · 1,380 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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