ALCON 00380650002518Recalls & reported problems
Alcon Laboratories, Inc. · 27GA Illuminated Flexible Curved Laser Probe · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380650002518), received between Nov 14, 2025 and Nov 14, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Defective Component” (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
- Defective Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 14, 2025Defective Component; Defective Component
A PHYSICIAN REPORTED THAT AN OPHTHALMIC LASER PROBE COULD NOT BE INSERTED INTO THE TROCAR DURING A COMBINED CATARACT AND VITRECTOMY PROCEDURE. THE SURGERY WAS SUCCESSFULLY COMPLETED AFTER THE DEVICE WAS REPLACED WITH ANOTHER ONE WITHOUT IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23554716 ↗
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- Directional Laser Probe with Alcon / Lumenis connector.(25 gauge / 0.5 mm) 7225.ALCD.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Laser, Ophthalmic1 recall0 reports
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- EVA, combined machine including Laser (SMA connector) 8000.COM03D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Laser, Ophthalmic20 reports
- Alcon, Engauge 8065751709Alcon Laboratories, Inc. · Laser, ophthalmic14 reports
- Alcon, Engauge 8065750991Alcon Laboratories, Inc. · Laser, ophthalmic10 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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