mi-eye 2 95mm T200-095Recalls & reported problems
Trice Medical, Inc. · mi-eye 2 probe 95mm length for use with Trice Tablet 2 · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00861578000331), received between Jun 19, 2019 and Mar 19, 2021 — classified as 3 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 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem3
Patient problems
- Unspecified Infection2
- Bacterial Infection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMar 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT PRESENTED WITH LOCAL INFECTION NEAR THE PROCEDURE SITE. PATIENT PROCEDURE INCLUDED A MI-EYE 2 CAMERA AS WELL AS SKIN PREPARATION MATERIALS, GEL-ONE, AND STEROID INJECTION THROUGH LUER PORT OF MI-EYE 2. PHYSICIAN DESCRIBED THAT THE PATIENT REQUIRED SURGERY TO CLEAN THE INFECTION SITE AND REQUIRED A COURSE OF ANTIBIOTICS TO BE ADMINISTERED IN THE HOSPITAL. THE PHYSICIAN DESCRIBED THAT HE USED TYPICAL SKIN PREPARATION PROCEDURES TO CLEAN THE PROCEDURE SITE PRIOR TO INSERTION OF THE TRICE MI-EYE 2 CAMERA ENABLED PROBE.
Patient problems: Bacterial Infection
MAUDE report 11529573 ↗InjuryAug 2, 2019Adverse Event Without Identified Device or Use Problem
AFTER A MARKETING DEMO PROCEDURE, PATIENT HAD AN INFECTED KNEE AND WAS ADMITTED TO THE HOSPITAL. PATIENT'S KNEE WAS WASHED OUT WITH ANTIBIOTICS.
Patient problems: Unspecified Infection
MAUDE report 8855216 ↗InjuryJun 19, 2019Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AFTER A MARKETING DEMO PROCEDURE, THE PT DEVELOPED AN INFECTED KNEE AND WAS ADMITTED TO THE HOSPITAL. AT THIS POINT, THE PT'S KNEE WAS WASHED OUT WITH ANTIBIOTICS. FDA SAFETY REPORT ID# (B)(4).
Patient problems: Unspecified Infection
MAUDE report 8717323 ↗
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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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