UNITY TETRASPOT 00380650002372Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00380650002372), received between Jul 24, 2025 and Jul 17, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Defective Component” (7 reports).

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

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 17, 2026Defective Component

  Patient problems: Insufficient Information

  MAUDE report 25856029 ↗
• MalfunctionJun 18, 2026Defective Component

  A PHYSICIAN REPORTED THAT DURING SETUP OPHTHALMIC LASER PROBE DID NOT PASS THROUGH THE OPHTHALMIC TROCAR. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH ALTERNATIVE PRODUCT AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25548794 ↗
• MalfunctionMar 26, 2026Defective Component

  A PHYSICIAN REPORTED THAT AN OPTHALMIC LASER PROBE WOULD NOT BE INSERTED INTO TROCAR DURING THE SURGERY. THE DETAILS OF THE SURGERY AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 24695809 ↗
• MalfunctionDec 19, 2025Fitting Problem; Fitting Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING VITRECTOMY SURGERY, AN OPHTHALMIC LASER PROBE DID NOT PASS SMOOTHLY THROUGH THE CANNULA AND APPEARED TO CATCH OR GET STUCK IN IT. HOWEVER, THE NEW LASER PROBE FROM THE SAME LOT NUMBER HAD SOME DIFFICULTY PASSING SMOOTHLY BUT WAS BETTER. THE SURGERY WAS COMPLETED ON THE SAME DAY USING THE NEW PROBE. PATIENT HARM WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, NONE RECEIVED TILL DATE.

  Patient problems: Insufficient Information

  MAUDE report 23847728 ↗
• MalfunctionNov 7, 2025Defective Component; Defective Component

  A PHYSICIAN REPORTED THAT DURING THE DEMONSTRATION OF AN OPTHALMIC LASER PROBE DID NOT FIT INTO THE TROCAR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23497767 ↗
• MalfunctionNov 5, 2025Defective Component; Defective Component

  A PHYSICIAN REPORTED THAT DURING SURGERY TWO LASER PROBES FROM THE SAME LOT WOULD NOT FIT INTO THE TROCAR CANNULAS. PROCEDURE DETAILS AND PATIENT HARM WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23476808 ↗
• MalfunctionAug 13, 2025Fitting Problem; Defective Component; Fitting Problem; Defective Component

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT LASER PROBE WAS UNABLE TO ENTER INTO THE TROCAR AFTER MULTIPLE ATTEMPTS. PROCEDURE DETAILS AND PATIENT HARM WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22792515 ↗
• MalfunctionAug 7, 2025Fitting Problem; Fitting Problem

  A CUSTOMER REPORTED THAT DURING INSTALLATION AN OPHTHALMIC LASER PROBE WOULD NOT FIT INTO THE CANNULA. THE PROCEDURE WAS COMPLETED WITH A NEW LASER PROBE. PATIENT HARM WAS NOT REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22736995 ↗
• MalfunctionJul 24, 2025Energy Output Problem; Defective Component; Energy Output Problem; Defective Component

  A PHYSICIAN REPORTED THAT DURING CATARACT AND VITRECTOMY SURGERY LASER EMISSION FAILURE OCCURRED AND IT WAS DIFFICULT TO BE INSERTED IN AN OPHTHALMIC TROCAR FOR THREE OF THE OPHTHALMIC LASER PROBES FROM SAME LOT. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE AND THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22585469 ↗