TECNIS ODYSSEY TORIC II IOL DRT150 (REF DRT1500155)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474811263), received between Feb 13, 2025 and Sep 25, 2026 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Halo; Visual Disturbances

  MAUDE report 50903343 ↗
• InjuryApr 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED TORIC INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE RIGHT EYE DUE TO AN UNKNOWN REASON. THE REPLACEMENT LENS WAS ANOTHER JOHNSON AND JOHNSON (DRT150 14.0). THE DOUVISC WAS USED AS VISCOELASTIC. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 24793461 ↗
• InjuryApr 2, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT THE FIRST EYE SURGERY WITH A TECNIS ODYSSEY TORIC SIMPLICITY INTRAOCULAR LENS (IOL) IS NOT RECEIVING THE EXPECTED NEAR VISION POST-OPERATION. THE PATIENT'S VISUAL ACUITY MEASUREMENTS WERE PROVIDED AS DISTANCE VISION (DV): 20/20, PINHOLE (PH): 20/25 -2, NEAR VISION (NV): J8, MANIFEST REFRACTION (MR) +0.25 +0.50 X021 20/25 -1, AND ADD +2.00 J1+. PATIENT STATED HIS DISTANCE VISUAL ACUITY SEEMS PRETTY GOOD BUT EXPERIENCED INTERMITTENT HAZY VISION IN THE OPERATED EYE (OS) AND STRUGGLES WITH NEAR VISION TASKS, HE CANNOT SEE HIS COMPUTER WITH HIS LEFT EYE. NO PAIN OR DISCOMFORT HAS BEEN REPORTED, AND THE PATIENT HAS NOT BEEN USING TEAR DROPS. NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (NSAID) AND STEROID DROPS ARE SCHEDULED AS PART OF THE MEDICAL INTERVENTION. THE SECOND EYE SURGERY FOR RIGHT IS PLANNED FOR ON (B)(6) 2025. THE POSSIBILITY OF EXPLANTING THE LEFT LENS IS BEING CONSIDERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 21756279 ↗
• MalfunctionFeb 13, 2025Device Difficult to Setup or Prepare; Scratched Material; Device Difficult to Setup or Prepare; Scratched Material

  THE PRE-LOADED DRT150 MODEL INTRAOCULAR LENS (IOL) WAS INJECTED INTO THE PATIENT'S OCULAR SINISTER (LEFT EYE) AND THE LENS WAS GORGED ON THE OUTER SIDE OF THE LENS. THE DAMAGE WAS CLARIFIED AS A DEEP SCRATCH ON THE PERIPHERAL EDGE. DUE TO THE PERIPHERAL LOCATION OF THE SCRATCH, THE SURGEON DECIDED TO LEAVE THE IOL IMPLANTED. THE DOCTOR STATED IT WAS A LITTLE TIGHT WHEN HE PUSHED THE LENS IN. IT IS UNKNOWN IF THE INCISION WAS ENLARGED HOWEVER, THERE WAS NO MEDICAL ATTENTION, NO MEDICATION WAS PRESCRIBED, NO PROCEDURAL DELAYS, NO SUTURES, AND NO VITRECTOMY DURING THE PROCEDURE. VISCOELASTIC WAS USED AND THE SURGICAL TECHNICIAN IS EXPERIENCED WITH PRE-LOADED LENSES. THE LENS ARE KEPT IN A SEPARATE ROOM WITHIN TEMPERATURE OUTSIDE THE OPERATING ROOM (OR). PATIENT'S DAILY ACTIVITIES SIGNIFICANTLY WERE NOT AFFECTED. PATIENT PROGNOSIS POST-PROCEDURE WAS REPORTED AS FULLY RECOVERED. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT REMAINS IMPLANTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21381932 ↗
• MalfunctionFeb 13, 2025Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE SURGEON NOTICED THE LENS WAS SCRATCHED AND UPON EXAMINATION UNDER THE MICROSCOPE, IT WAS CONFIRMED. THIS LENS DID NOT COME INTO CONTACT WITH A PATIENT AND NO PATIENT WAS PRESENT IN THE ROOM AT THE TIME OF OPENING OR TESTING THE LENS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21381560 ↗