ULTRA FLOW 00380658170011Recalls & reported problems
Alcon Laboratories, Inc. · ULTRAFLOW S/P STRAIGHT TIP, .3MM · Class 2
All models of ULTRA FLOW (2)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380658170011), received between Aug 6, 2021 and Jun 24, 2022 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (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.
Most reported problems
Device problems
- Break1
- Material Deformation1
Patient problems
- Capsular Bag Tear1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 24, 2022Break; Break
A CUSTOMER REPORTED THAT AN OPHTHALMIC IRRIGATION/ASPIRATION TIP WAS BROKEN. PROCEDURE DETAILS WERE NOT PROVIDED. NO IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14796458 ↗InjuryAug 6, 2021Material Deformation; Material Deformation
A CUSTOMER REPORTED THAT DURING A CATARACT SURGERY THE IRRIGATION/ASPIRATION(I/A) TIP A I/A HANDPIECE WAS FOUND TO HAVE A BURR. THERE WAS NO REPORT OF PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT POSTERIOR CUT HAPPENED WHILE CORTICAL CLEANING. THE INTRAOCULAR LENS(IOL) WAS PLACED TO TAMPONADE THE HOLE IN POSTERIOR CAPSULE. THERE WAS NO VITREOUS PRESENT. NO SURGICAL OR MEDICAL INTERVENTION WAS REQUIRED.
Patient problems: Capsular Bag Tear
MAUDE report 12291841 ↗
Other NEEDLE, HYPODERMIC, SINGLE LUMEN, REPROCESSED devices
- ULTRA FLOW 8065751795Alcon Laboratories, Inc. · NEEDLE, HYPODERMIC, SINGLE LUMEN, REPROCESSED22 reports
- INTREPID® 8065751013Alcon Laboratories, Inc. · NEEDLE, HYPODERMIC, SINGLE LUMEN, REPROCESSED10 reports
- INTREPID® 8065751012Alcon Laboratories, Inc. · NEEDLE, HYPODERMIC, SINGLE LUMEN, REPROCESSED8 reports
- ALCON 8065740970Alcon Laboratories, Inc. · NEEDLE, HYPODERMIC, SINGLE LUMEN, REPROCESSED3 reports
- ALCON 8065740969Alcon Laboratories, Inc. · NEEDLE, HYPODERMIC, SINGLE LUMEN, REPROCESSED2 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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