Vortex Surgical Inc. VS0135.25Recalls & reported problems
Vortex Surgical, Inc. · 25ga Illuminated Flex-Tip Laser Probe · Class 2
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
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810123483617), received between Jan 15, 2026 and Jan 15, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Accessory Incompatible” (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
- Nov 19, 2025Open, Classified
Reason for the voluntary recall is some products in this lot are not passing through a 25ga cannula smoothly.
Z-1004-2026 · Root cause: Component design/selection · Recall details · FDA record ↗
Most reported problems
Device problems
- Accessory Incompatible1
Patient problems
- Unspecified Eye / Vision Problem1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 15, 2026Accessory Incompatible
SURGEON HAD DIFFICULTY GETTING VS0135.25 ILLUMINATED FLEX-TIP LASER PROBE TO PASS THROUGH TRANSITION OF THE CANNULA. CANNULA PULLED OUT OF THE EYE. NO PATIENT HARM NOTED BY SURGEON.
Patient problems: Unspecified Eye / Vision Problem
MAUDE report 24078620 ↗
Other Photocoagulator And Accessories devices
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- Vortex Surgical Inc VS0125.25BVortex Surgical, Inc. · Photocoagulator And Accessories1 recall0 reports
- Vortex Surgical Inc VS0120.25Vortex Surgical, Inc. · Photocoagulator And Accessories1 recall0 reports
- Vortex Surgical Inc VS0140.25Vortex Surgical, Inc. · Photocoagulator And Accessories1 recall0 reports
- Vortex Surgical Inc VS0120.23Vortex Surgical, Inc. · Photocoagulator And Accessories1 recall0 reports
- Vortex Surgical Inc VS0130.25Vortex Surgical, Inc. · Photocoagulator And Accessories1 recall0 reports
- Vortex Surgical Inc VS0110.25Vortex Surgical, Inc. · Photocoagulator And Accessories1 recall0 reports
- Alcon, Engauge 8065751593Alcon Laboratories, Inc. · Photocoagulator and accessories28 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 · 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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