UNITYRecalls & reported problems across all models
Alcon Laboratories, Inc. · 19 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one UNITY model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 470
- Deaths reported
- 0
- Injuries reported
- 66
- Recalls
- 2
We found 19 models of UNITY by Alcon Laboratories, Inc. in the FDA's device registry (GUDID). Together they are named in 470 adverse event reports in the FDA's MAUDE database, received between Aug 25, 2024 and Sep 30, 2026 — classified as 66 injuries, 404 malfunctions.
The most frequently reported specific device problem is “Improper Flow or Infusion” (108 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 still open.
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
UNITY recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Aug 5, 2025Open, Classified
Due to incomplete seals in the pouch which provide the sterile barrier.
Z-0308-2026 · Root cause: Process control · Recall details · FDA record ↗
- Aug 5, 2025Open, Classified
Due to incomplete seals in the pouch which provide the sterile barrier.
Z-0304-2026 · Root cause: Process control · names 3 of these models · Recall details · FDA record ↗
Most reported UNITY problems
Device problems
- Improper Flow or Infusion108
- Suction Problem86
- Failure to Cut46
- No Device Output36
- Suction Failure36
- Pressure Problem28
- Adverse Event Without Identified Device or Use Problem27
- Air/Gas in Device24
Patient problems
- No Clinical Signs, Symptoms or Conditions187
- Insufficient Information186
- Intraocular Pressure Decreased50
- Corneal Edema21
- Blurred Vision15
- Capsular Bag Tear14
- Eye Injury8
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available7
UNITY models
19 models, most reported first. Each model has its own page with its reports, recalls and device details.
- UNITY 00380650002969Instrument, Vitreous Aspiration And Cutting, Ac-Powered271 reports
- UNITY 00380650002501Vitrectomy, Instrument Cutter1 recall5 reports
- UNITY 00380657531684Vitrectomy, Instrument Cutter1 recall3 reports
- UNITY 00380650004680Cannula, Trocar, Ophthalmic1 recall1 report
- UNITY 00380657531790Vitrectomy, Instrument Cutter1 recall1 report
- UNITY 00380650004789Instrument, Vitreous Aspiration And Cutting, Ac-Powered27 reports
- UNITY 00380650003393Unit, Phacofragmentation23 reports
- UNITY 00380650004840Instrument, Vitreous Aspiration And Cutting, Ac-Powered21 reports
- UNITY 00380650002976Unit, Phacofragmentation20 reports
- UNITY 00380650003317Instrument, Vitreous Aspiration And Cutting, Ac-Powered18 reports
- UNITY 00380650004857Instrument, Vitreous Aspiration And Cutting, Ac-Powered16 reports
- UNITY 00380650003836Instrument, Vitreous Aspiration And Cutting, Ac-Powered15 reports
- UNITY 00380650003348Instrument, Vitreous Aspiration And Cutting, Ac-Powered14 reports
- UNITY 00380650003157Unit, Phacofragmentation13 reports
- UNITY 00380650003829Instrument, Vitreous Aspiration And Cutting, Ac-Powered8 reports
- UNITY 00380650003409Unit, Phacofragmentation7 reports
- UNITY 00380650003423Unit, Phacofragmentation5 reports
- UNITY 00380650003201Unit, Phacofragmentation1 report
- UNITY 00380650003416Unit, Phacofragmentation1 report
Recent UNITY adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Capsular Bag Tear
MAUDE report 50952764 ↗MalfunctionSep 30, 2026Air/Gas in Device
A physician reported that air flowed from air line when infusion was clamped during surgery. The procedure type was unknown. The surgery was completed on the same day by replacing the product with another one. There was no patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943434 ↗MalfunctionSep 30, 2026Improper Flow or Infusion
A healthcare professional reported that air infusion failure (did not come out even though the air was put on) occurred during vitrectomy surgery. The surgery was completed on the same day after replacing the product with a new infusion line. There was no patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943432 ↗MalfunctionSep 30, 2026Failure to Cut
A physician reported that actuation failure of the cutter occurred during surgery. The procedure type was unknown. The surgery was completed after replacing it with another product. There was no patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943275 ↗MalfunctionSep 29, 2026Suction Problem
A physician reported that the aspiration pressure did not rise during surgery. The procedure type was unknown. The surgery was completed on same day after replacing the product with another one. There was no patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934794 ↗MalfunctionSep 29, 2026Failure to Cut
A health care professional reported that vitrectomy probe had poor cutting during surgery. The surgery was completed on the same day after replacing the cassette with another one. There was no information about patient impact.
Patient problems: Insufficient Information
MAUDE report 50934793 ↗MalfunctionSep 29, 2026Suction Problem; Failure to Cut
A healthcare professional reported that the vitrectome malfunctioned during surgery, as it failed to perform both cutting and vacuum functions. The procedure type was unknown. Even after reducing the cutting speed to 10000 cuts per minute (CPM) and changing the pump of the console the issue was not resolved. The procedure was able to continue after the affected vitrectome was replaced with a new one. It was unknown how the surgery was completed. There was no information about the patient impact.Additional information could not be obtained because the initial reporter declined further follow-up contact.
Patient problems: Insufficient Information
MAUDE report 50934512 ↗MalfunctionSep 29, 2026Suction Problem
A physician reported that the aspiration could not be performed during irrigation and aspiration mode of the surgery. The procedure type was unknown. The surgery was completed on same day after replacing the product with another one. There was no patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934511 ↗MalfunctionSep 29, 2026Suction Problem
A physician reported that aspiration failure of cutter occurred during vitrectomy surgery. The surgery was completed on the same day by changing the product. There was no patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933779 ↗MalfunctionSep 29, 2026No Device Output
A physician reported that an ophthalmic system exhibited no ultrasonic oscillation during surgery. The surgery was completed on the same day after the system was restarted and normal function was restored. The surgeon declined to provide any additional information.
Patient problems: Insufficient Information
MAUDE report 50931168 ↗MalfunctionSep 29, 2026Suction Problem
A physician reported that a vitrectomy probe aspiration issue occurred during a vitrectomy surgery. The surgery was completed on the same day after the product was replaced with another one. There was patient contact with the suspected product; however, no impact occurred to the patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50929026 ↗MalfunctionSep 29, 2026Use of Device Problem
A customer reported that faulty cutter during ophthalmic surgery. The surgery was completed but it was unknown how the surgery was completed. There was no patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927474 ↗MalfunctionSep 28, 2026Suction Problem
A physician reported that the aspiration pressure did not increase during the irrigation/aspiration mode. The surgery was completed on the same day after the product was replaced with another one. The procedure type was unknown. There was patient contact with the suspect product; however, no impact occurred to the patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916948 ↗MalfunctionSep 28, 2026Suction Problem
A physician reported that aspiration could not be performed at irrigation and aspiration (IA) mode during surgery. The surgery type was unknown. The surgery was completed on same day after replacing the same product with another one. There was patient contact with suspect product but no impact to the patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916284 ↗MalfunctionSep 28, 2026Incomplete or Inadequate Connection
A healthcare professional reported that the error message (loose tip) occurred, which made prime impossible before vitrectomy surgery. The surgery was completed on same day after replacing the product with another one. There was no patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916281 ↗
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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