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UltraQ Reflex LQP3106-U (UDI 09342395000038)Recalls & reported problems

Ellex Medical Pty Ltd · Red aiming beam · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 09342395000038), received between Sep 27, 2018 and Nov 11, 2018 — classified as 2 injuries.

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

  • Adverse Event Without Identified Device or Use Problem2

Patient problems

  • Retinal Injury2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryNov 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE EVENT OCCURED IN (B)(6), DOCTOR WAS TREATING A FLOATER ON A PATIENT . ENERGY: STARTED FROM 4MJ, AND INCREASED THE ENERGY GRADUALLY SINCE NOTHING WAS HAPPENING TO THE FLOATER. RETINAL BLEEDING HAPPENED AT 8MJ.

    Patient problems: Retinal Injury

    MAUDE report 8058542 ↗
  • InjurySep 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE EVENT OCCURED IN (B)(6), DOCTOR WAS TREATING A FLOATER ON A PATIENT AND ACCIDENTALLY HIT THE RETINA.

    Patient problems: Retinal Injury

    MAUDE report 7917226 ↗

Other Laser, Ophthalmic devices

All Laser, Ophthalmic devices →

Sources and updates

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