UNITY 00380650003423Recalls & reported problems
Alcon Laboratories, Inc. · UNITY Cataract FMS Pack, 45° Hybrid Tip with Ultra Infusion Sleeves · Class 2
All models of UNITY (19)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380650003423), received between Jul 23, 2025 and Aug 14, 2026 — classified as 1 injury, 4 malfunctions.
The most frequently reported specific device problem is “Suction Problem” (2 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Suction Problem2
- Appropriate Device Problem Term/Code Not Available1
- Device Contamination with Chemical or Other Material1
- Incomplete or Inadequate Connection1
- Obstruction of Flow1
- Particulates1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Wound Dehiscence1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 14, 2026Particulates; Use of Device Problem; Device Contamination with Chemical or Other Material; Incomplete or Inadequate Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50249818 ↗MalfunctionAug 14, 2026Appropriate Device Problem Term/Code Not Available
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50249814 ↗InjuryDec 17, 2025Obstruction of Flow; Obstruction of Flow
A CUSTOMER REPORTED THAT PHACOEMULSIFICATION WOUND BURN OCCURRED AT AN UNKNOWN TIMING. THE SURGERY DETAILS WERE UNKNOWN. THERE WAS NO REPORT OF PATIENT CONDITION. ADDITIONAL INFORMATION WAS RECEIVED THAT OBSTRUCTION OF FLOW OCCURRED WHICH LEAD TO PHACO WOUND BURN FOR CATARACT WITH LENS IMPLANT SURGERY AND THE WOUND WAS SUTURED. THIS REPORT PERTAINS TO PHACOEMULSIFICATION TIP INVOLVED IN THIS REPORTED EVENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Wound Dehiscence
MAUDE report 23826248 ↗MalfunctionJul 25, 2025Suction Problem; Suction Problem
A PHYSICIAN REPORTED THAT THE ADVISORY CODE WAS DISPLAYED AND ASPIRATION BECAME IMPOSSIBLE DURING CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANTATION. HOWEVER, WHEN THE CONTINUOUS ASPIRATION WAS RESTARTED, ASPIRATION BECOMES POSSIBLE. THIS HAPPENED REPEATEDLY. THE PROCEDURE WAS COMPLETED WITHOUT PRODUCT REPLACEMENT. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22609346 ↗MalfunctionJul 23, 2025Suction Problem; Suction Problem
THE PHYSICIAN REPORTED THAT ASPIRATION STOPPED WHILE USING THE ULTRASOUND AND IRRIGATION/ASPIRATION (US/IA) MODE. THE ERROR CODE WAS CLEARED, AND IRRIGATION WAS TURNED OFF AND ON A FEW TIMES TO RESTORE FLOW DURING THE CATARACT [WITH INTRAOCULAR LENS (IOL) IMPLANT] SURGERY. THE SURGERY WAS COMPLETED. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22575105 ↗
Other Unit, Phacofragmentation devices
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- Constellation, Ultravit, 25+, TotalPlus, EdgePlus 8065751617Alcon Laboratories, Inc. · Unit, phacofragmentation2 recalls398 reports
- Alcon 8065752201Alcon Laboratories, Inc. · Unit, phacofragmentation1 recall386 reports
- Alcon 8065752200Alcon Laboratories, Inc. · Unit, phacofragmentation1 recall366 reports
- Constellation, Ultravit, 25+, TotalPlus, EdgePlus 8065751767Alcon Laboratories, Inc. · Unit, phacofragmentation2 recalls302 reports
- Constellation, ULTRAVIT, Engauge, 25+ 8065752415Alcon Laboratories, Inc. · Unit, phacofragmentation369 reports
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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