CenturionRecalls & reported problems across all models
Alcon Laboratories, Inc. · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,967
- Deaths reported
- 0
- Injuries reported
- 511
- Recalls
- 0
We found 5 models of Centurion by Alcon Laboratories, Inc. in the FDA's device registry (GUDID). Together they are named in 1,967 adverse event reports in the FDA's MAUDE database, received between Mar 2, 2021 and Sep 29, 2026 — classified as 511 injuries, 1,456 malfunctions.
The most frequently reported specific device problem is “Failure to Deliver Energy” (263 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 Centurion problems
Device problems
- Adverse Event Without Identified Device or Use Problem315
- Failure to Deliver Energy263
- Suction Problem214
- Energy Output Problem165
- Unexpected Shutdown161
- Appropriate Device Problem Term/Code Not Available151
- Decrease in Suction144
- Suction Failure144
Patient problems
- No Clinical Signs, Symptoms or Conditions1,090
- Insufficient Information331
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available176
- Corneal Edema113
- Eye Burn111
- Toxic Anterior Segment Syndrome (TASS)106
- Capsular Bag Tear88
- Blurred Vision65
Centurion models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Centurion 8065751763Unit, phacofragmentation728 reports
- Centurion 8065753057Unit, phacofragmentation639 reports
- CENTURION® 8065752914Unit, phacofragmentation571 reports
- Centurion 8065751762Instrument, vitreous aspiration and cutting, ac-powered27 reports
- Centurion 8065000565Unit, Phacofragmentation2 reports
Recent Centurion adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Suction Problem
A physician reported that the ophthalmic systems vacuum level did not increase as expected in ultrasound mode during phacoemulsification. The footswitch was inspected for any foreign material, and the handpiece was checked for leakage; however, no abnormalities were found. The vacuum level still did not increase thereafter. The procedure was completed without further intervention. There was no further patient impact was reported.
Patient problems: Insufficient Information
MAUDE report 50930863 ↗MalfunctionSep 29, 2026Improper Flow or Infusion; Audible Prompt/Feedback Problem
A nurse reported that during cataract surgery, the ophthalmic system displayed a system message code. While aspirating the viscoelastic following lens insertion, a strange sound was heard, and no fluid was flowing through the irrigators. The procedure was completed on the same day. Information regarding the patient has not been provided.
Patient problems: Insufficient Information
MAUDE report 50930044 ↗MalfunctionSep 28, 2026No Device Output
Patient problems: Insufficient Information
MAUDE report 50924040 ↗MalfunctionSep 25, 2026Unexpected Shutdown
A customer reported that after cataract surgery an ophthalmic operating system was shutdown automatically while removing the cassette. The surgery was completed causing no impact on the patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50897342 ↗MalfunctionSep 25, 2026No Device Output
A customer reported that the operating handpiece on the ophthalmic console successfully completed prime and tune but did not deliver phacoemulsification energy when used in the eye. Procedure details were not provided. No patient impact was reported.This complaint is pertaining the system issue received from the initial reporter.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50895296 ↗MalfunctionSep 25, 2026Unexpected Shutdown
A customer reported that, an ophthalmic system shutdown on its own. Procedure details and patient impact have not been provided. Additional information has been requested, none received at this time of report.
Patient problems: Insufficient Information
MAUDE report 50895066 ↗MalfunctionSep 25, 2026No Device Output
The physician reported that during surgery ophthalmic console exhibited no ultrasound power output. The issue was resolved after replacing the wire and the surgery was completed on same day without any patient health impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50894261 ↗InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
A physician reported that patients developed Toxic Anterior Segment Syndrome (TASS) following a procedure involving an ophthalmic handpiece. Procedure details and current condition of patients have not been provided. Additional information has been requested but is not available at the time of this report.Additional information received indicated that a cataract procedure on the right eye had been scheduled.
Patient problems: Toxic Anterior Segment Syndrome (TASS)
MAUDE report 50815342 ↗MalfunctionSep 18, 2026No Device Output
A physician reported that during surgery, an ophthalmic system ultrasound output ceased during ultrasound. The surgery was completed after repriming. There was no further patient impact was reported.
Patient problems: Insufficient Information
MAUDE report 50814739 ↗MalfunctionSep 17, 2026Suction Problem
A customer reported that ophthalmic console exhibited issue with vacuum in quadrant mode of the surgery. The procedure details and patient impact was not reported.
Patient problems: Insufficient Information
MAUDE report 50800778 ↗InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem
A Physician reported that patient developed endophthalmitis postoperatively. Procedure details and the patient¿s clinical outcome were not reported. Additional information has been requested but none has been provided to date.
Patient problems: Endophthalmitis
MAUDE report 50784609 ↗MalfunctionSep 15, 2026No Device Output
A customer reported that during cataract surgery handpiece stopped working during phacoemulfication. Procedure was completed by using new handpiece and there was no patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50772309 ↗MalfunctionSep 15, 2026No Device Output
A customer reported that an ophthalmic console did not perform phacoemulsification during the cataract surgery. The patient impact was reported as unknown. The surgery completion status was not reported. Additional information has been requested but is not available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50766982 ↗InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem
A physician reported that, following cataract surgeries performed using an ophthalmic system and ophthalmic handpieces, multiple patients experienced significant corneal edema and swelling on postoperative day one. The physician stated that all 16 patients evaluated on the first postoperative day presented with significant corneal edema, reduced visual acuity of 20/100 or worse, at least 1+ Descemet¿s folds, and 1+ microcystic edema. The patients' current condition is unknown. The physician further reported that the ophthalmic system and handpieces successfully passed Prime and Tune testing, and no Advisory Codes were generated.It was reported that there was no indication that these handpieces were used in the procedures.This report pertains to the tenth of twelve different handpieces reported from the same facility.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Corneal Edema; Swelling/ Edema
MAUDE report 50756252 ↗InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem
A physician reported that, following cataract surgeries performed using an ophthalmic system and ophthalmic handpieces, multiple patients experienced significant corneal edema and swelling on postoperative day one. The physician stated that all 16 patients evaluated on the first postoperative day presented with significant corneal edema, reduced visual acuity of 20/100 or worse, at least 1+ Descemet¿s folds, and 1+ microcystic edema. The patients' current condition is unknown. The physician further reported that the ophthalmic system and handpieces successfully passed Prime and Tune testing, and no Advisory Codes were generated.It was reported that there was no indication that these handpieces were used in the procedures.This report pertains to the nineth of twelve different handpieces reported from the same facility.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Corneal Edema; Swelling/ Edema
MAUDE report 50756251 ↗
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
- ACRYSOF353 models · 1,890 reports
- AcrySof UltraSert102 models · 1,467 reports · 1 recall
- MONARCH III2 models · 1,380 reports · 1 recall
- ClearCut17 models · 531 reports · 13 recalls
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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