ASSEMBLY, TOP 5mm LS SLA, HS 13880-01Recalls & reported problems
Iridex Corporation · Class 2
Data updated Oct 18, 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 00813125011345), received between Apr 19, 2019 and Apr 19, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 19, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IRIDEX RECEIVED A REPORT INDICATING THAT THE SLITLAMP ADAPTER (SLA) TREATMENT BEAM AND AIMING BEAM WERE SUPERIMPOSED. THIS COULD RESULT IN TREATMENT OF AN UNINTENDED AREA.
Patient problems: No Patient Involvement
MAUDE report 8533616 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page