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Tango LT5106-TRecalls & reported problems

Ellex Medical Pty Ltd · Class 2

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 09342395000113), received between Jan 18, 2021 and Feb 17, 2022 — 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem2
  • Appropriate Device Problem Term/Code Not Available1

Patient problems

  • Visual Impairment2

Recent adverse event reports

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

  • InjuryFeb 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THERE WAS AN INCIDENT REPORTED ON THE ELLEX TANGO LASER MACHINE(S/N: (B)(4)) USED IN AN (B)(6) EYE CLINIC. DURING YAG CAPSULOTOMY, THE DOCTOR ACCIDENTALLY SET THE LASER MODE TO SLT INSTEAD OF YAG RESULTING INPATIENT EYE DAMAGE. THIS REPORT IS MADE BY ELLEX WITHOUT PREJUDICE AND DOES NOT IMPLY ANY ADMISSION OF LIABILITY FOR THE INCIDENT OR ITS CONSEQUENCES.

    Patient problems: Visual Impairment

    MAUDE report 13553211 ↗
  • InjuryJan 18, 2021Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

    THERE WAS AN INCIDENT REPORTED ON THE ELLEX TANGO LASER MACHINE(S/N: (B)(6)) USED IN AN IRELAND EYE CLINIC. THE USERS HAVE INDICATED THAT THE INCIDENT HAS ADVERSELY AFFECTED THE PATIENT'S VISION. THIS REPORT IS MADE BY ELLEX WITHOUT PREJUDICE AND DOES NOT IMPLY ANY ADMISSION OF LIABILITY FOR THE INCIDENT OR ITS CONSEQUENCES.

    Patient problems: Visual Impairment

    MAUDE report 11183900 ↗

Other Laser, Ophthalmic devices

All Laser, Ophthalmic devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.