UNITY 00380650003416Recalls & reported problems
Alcon Laboratories, Inc. · UNITY Cataract FMS Pack, 30° 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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380650003416), received between Jun 11, 2025 and Jun 11, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Obstruction of Flow” (1 report).
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
- Obstruction of Flow1
Patient problems
- Eye Burn1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 11, 2025Obstruction of Flow; Obstruction of Flow
A CUSTOMER REPORTED THAT DURING REFRACTIVE LENS EXCHANGE, FEMTOSECOND LASER, BILATERAL SURGERY WITH AN OPHTHALMIC SYSTEM AND PHACOEMULSIFICATION TIP. THE TIP WAS OCCLUDED WITH VISCOELASTIC IN PRE PHACOEMULSIFICATION STEP, SURGEON ADVANCED TO EPI SURGICAL STEP, OCCLUSION FAILED TO CLEAR, AND SURGEON MOVED TO SCULPT SURGICAL STEP AND WAS ABLE TO CLEAR OCCLUSION AND CORNEAL BURN OCCURRED FOR WHICH ONE SUTURE WAS PLACED. THE PROCEDURE WAS COMPLETED ON SAME DAY. THIS REPORT PERTAINS TO PHACOEMULSIFICATION TIP INVOLVED IN THIS REPORTED EVENT.
Patient problems: Eye Burn
MAUDE report 22186198 ↗
Other Unit, Phacofragmentation devices
- Centurion 8065751763Alcon Laboratories, Inc. · Unit, phacofragmentation728 reports
- Centurion 8065753057Alcon Laboratories, Inc. · Unit, phacofragmentation639 reports
- CENTURION® 8065752914Alcon Laboratories, Inc. · Unit, phacofragmentation571 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page