UNITY 00380650004680Recalls & reported problems
Alcon Laboratories, Inc. · 27GA Infusion Cannula (includes TMD) – for use with 4mm/6 mm ES · Class 1
All models of UNITY (19)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380650004680), received between Mar 28, 2025 and Mar 28, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Failure to Seal” (1 report).
1 FDA recall record name this device's identifier, 1 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, 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
Recalls naming this device
- 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 ↗
Most reported problems
Device problems
- Failure to Seal1
Patient problems
- Endophthalmitis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 28, 2025Failure to Seal; Failure to Seal
A PHYSICIAN REPORTED THAT THE SURGEON DID OBSERVE THAT THE INFUSION CANNULA WAS NOT SEALING ON THE CANNULA DURING THE CASE AND PATIENT DEVELOPED A POSTOPERATIVE DAY 3 (POD3) ENDOPHTHALMITIS AFTER SURGERY WHICH WAS CONFIRMED WITH A VITRECTOMY TAP AND SUCCESSFULLY TREATED WITH ANTIBIOTICS. THE PROCEDURE DETAILS WERE UNKNOWN.
Patient problems: Endophthalmitis
MAUDE report 21721556 ↗
Other Cannula, Trocar, Ophthalmic devices
- ALCON 00380650004673Alcon Laboratories, Inc. · Cannula, Trocar, Ophthalmic1 recall0 reports
- ALCON 00380650003591Alcon Laboratories, Inc. · Cannula, Trocar, Ophthalmic1 recall0 reports
- ALCON 00380650003560Alcon Laboratories, Inc. · Cannula, Trocar, Ophthalmic1 recall0 reports
- ALCON 00380650003584Alcon Laboratories, Inc. · Cannula, Trocar, Ophthalmic1 recall0 reports
- MANI Trocar Kit MTK25S TROCAR KIT 25G SMani, Inc. · Cannula, trocar, ophthalmic1 recall0 reports
- High flow infusion line for 20, 23, 25 & 27G cannula system 1279.HFD.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Cannula, Trocar, Ophthalmic2 reports
- ALCON 00380650003539Alcon Laboratories, Inc. · Cannula, Trocar, Ophthalmic1 report
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 · each recall links to the FDA recall notice
- 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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