TECNIS ODYSSEY TORIC II IOL DRT375 (REF DRT3750220)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474813168), received between Mar 20, 2025 and Feb 2, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (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

Recent adverse event reports

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

• InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S LEFT EYE. DURING A POST-OPERATIVE EXAMINATION, THE PATIENT COMPLAINED OF THEIR NEAR VISION NOT BEING CLEAR AND THEIR VISION OVERALL IS FUZZY WITH SHADOWS. THE PATIENT HAD TROUBLE DRIVING AT NIGHT DUE TO HALOS. REPORTEDLY THE DIRECTIONS FOR USE WERE FOLLOWED. THE IOL WAS EXPLANTED AND REPLACED WITH A NON-JOHNSON AND JOHNSON LENS, MODEL ETN500 +21.5. THE PATIENT¿S BEST CORRECTED VISUAL ACUITY (BSCVA) PRE-OPERATIVE WAS 20/30 AND POST-OPERATIVE WAS 20/25 +1. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, SUTURES, OR DELAY IN PROCEDURE. NO MEDICATION OUTSIDE THE STANDARD OF CARE. THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE REGARDING THIS EVENT.

  Patient problems: Blurred Vision; Vitreous Floaters

  MAUDE report 24229185 ↗
• InjuryMar 20, 2025Device Difficult to Setup or Prepare; Use of Device Problem; Scratched Material; Device Difficult to Setup or Prepare; Use of Device Problem; Scratched Material

  WHEN SURGEON TRIED TO INSERT THE PRE-LOADED DRT375 MODEL INTRAOCULAR LENS (IOL), THE INSERTER DID NOT FIT INTO THE 2.4MM WOUND, AND THE INCISION WAS ENLARGED. THE DOCTOR THEN PROCEEDED TO TURN THE KNOB AND FELT HEAVY RESISTANCE. AFTER LENS INSERTION, MULTIPLE SCRATCHES WERE OBSERVED IN THE CENTER AND PERIPHERY OF THE LENS. ABOUT TWO (02) HOURS LATER THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH ANOTHER DRT375 22.0 DIOPTER IOL THAT WAS OBTAINED FROM ANOTHER FACILITY. THERE WAS NO SUTURES AND NO VITRECTOMY. PATIENT STATUS POST PROCEDURE WAS REPORTED AS FULLY RECOVERED. IT WAS REPORTED THE SURGICAL TECHNICIAN LOADING THE LENS HAS USED THIS INSERTER BEFORE. WHEN REVIEWING HE CONFIRMED THAT HE DID NOT OVERFILL INTO THE LENS CASE DURING HYDRATION. THE KNOB WAS TURNED MORE THAN HALF A ROTATION, PUSHING THE LENS TO THE TIP. SALES REP INFORMED HIM THAT HE NEEDS TO ONLY TURN A HALF ROTATION. BOTH BSS & OVD WERE USED. IT WAS INDICATED THE IOL DIRECTION FOR USE WERE NOT FOLLOWED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 21657475 ↗