Alcon, Engauge 8065751592Recalls & reported problems
Alcon Laboratories, Inc. · 23 GA Illuminated Flexible Curved Laser Probe · Class 2
All models of Alcon, Engauge (7)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380657515929), received between Mar 9, 2023 and Mar 5, 2026 — classified as 2 malfunctions.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Defective Component1
- Fitting Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 5, 2026Defective Component
A NURSE REPORTED THAT DURING A COMBINED CATARACT AND VITRECTOMY SURGERY, AN OPHTHALMIC LASER PROBE BECAME BENT WHILE ATTEMPTING TO INSERT IT INTO THE TROCAR CANNULA, MAKING IT UNUSABLE. THE SURGERY WAS COMPLETED ON THE SAME DAY USING A NEW LASER PROBE, AND THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24518728 ↗MalfunctionMar 9, 2023Fitting Problem; Fitting Problem
ADDITIONAL INFORMATION RECEIVED INDICATING THAT TIP OF THE TROCAR WAS TOO THICK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16510996 ↗
Other Laser, ophthalmic devices
- Illuminated Stepped Laser Probe, Curved With tapered tip for use in combinatio 7510.ALCD.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Laser, Ophthalmic1 recall3 reports
- Directional Laser Probe with Alcon / Lumenis connector.(23 gauge / 0.6 mm) 7223.ALCD.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Laser, Ophthalmic1 recall0 reports
- 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
- Directional Laser Probe with Alcon / Lumenis connector.(27 gauge / 0.4 mm) 7227.ALCD.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Laser, Ophthalmic1 recall0 reports
- EVA, combined machine including Laser (DORC connector) 8000.COM02D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Laser, Ophthalmic44 reports
- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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