TECNIS ODYSSEY TORIC II IOL DRT225 (REF DRT2250190)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474811928), received between Feb 3, 2025 and Oct 29, 2025 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED MULTIFOCAL TORIC INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE RIGHT EYE DUE TO THE PATIENT¿S COMPLAINTS OF INCREASED GLARE, HALOS, AND STARBURSTS WHILE DRIVING AT NIGHT. THE ISSUE WAS FIRST IDENTIFIED DURING A POST-OPERATIVE EXAMINATION. ANOTHER JOHNSON & JOHNSON LENS WAS IMPLANTED AS REPLACEMENT; DIU225 19.0 DIOPTER. THERE WERE NO UNPLANNED COMPLICATIONS, SUCH AS INCISION ENLARGEMENT, SUTURES, OR VITRECTOMY. NO MEDICAL ATTENTION OR MEDICATION OUTSIDE STANDARD OF CARE WAS REQUIRED AND THERE WERE NO SURGICAL DELAYS. THE PATIENT IS FULLY RECOVERED. DAILY ACTIVITIES ARE NOT AFFECTED. PRE-OPERATIVE BEST SPECTACLE CORRECTED VISUAL ACUITY (BSCVA) WAS 20/20-2 AND POST-OPERATIVE BSCVA WAS 20/20+1. IT WAS REPORTED THAT THE DIRECTIONS FOR USE WERE FOLLOWED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Flashers; Halo; Visual Disturbances

  MAUDE report 23416781 ↗
• InjurySep 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A TECNIS TORIC ODYSSEY INTRAOCULAR LENS (IOL) ON (B)(6) 2024, COMPLAINED OF VISUAL DISTURBANCES SUCH AS DIFFICULTY DRIVING AT NIGHT, GHOSTING, AND HALOS. THE PATIENT¿S PRE-OPERATIVE BEST SPECTACLE CORRECTED VISUAL ACUITY WAS 20/20-1, AND HER POST-OPERATIVE BEST SPECTACLE CORRECTED VISUAL ACUITY WAS 20/25+1. ON (B)(6) 2025, THE LENS WAS EXPLANTED DURING A SECONDARY SURGERY. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS, SUCH AS UNPLANNED INCISION ENLARGEMENT, SUTURES, VITRECTOMY, OR PROCEDURAL DELAYS. THE PATIENT WAS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Flashers; Halo

  MAUDE report 22948722 ↗
• MalfunctionAug 23, 2025Break; Break

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS CRACKED. THE IOL WAS PARTIALLY INSERTED AND THEN REMOVED BECAUSE MULTIPLE CRACKS WERE NOTICED ON THE OPTIC. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A REPLACEMENT IOL OF THE SAME MODEL AND DIOPTER. THERE WAS NO PATIENT INJURY, NO VITRECTOMY, SUTURES AND INCISION ENLARGEMENT. REPORTEDLY, THE PATIENT IS DOING WELL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22881327 ↗
• MalfunctionFeb 3, 2025Break; Device Difficult to Setup or Prepare; Break; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT THE PRELOADED LENS WAS DIFFICULT TO ADVANCE, ADVANCED VERY QUICKLY AND CAME OUT IN MULTIPLE PARTS DURING INSERTION INTO THE EYE, LEADING TO PATIENT CONTACT WITH THE IOL. THE LENS WAS SUBSEQUENTLY REPLACED WITH THE SAME MODEL DIOPTER IOL DURING THE SAME PROCEDURE. THE PATIENT IS NOW SATISFIED WITH THEIR VISION, WHICH IS 20/15. NO INJURY OR ADDITIONAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21298475 ↗