TECNIS ODYSSEY TORIC II IOL DRT225 (REF DRT2250180)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474811904), received between Feb 6, 2026 and Jul 31, 2026 — classified as 2 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

Recent adverse event reports

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

• InjuryJul 31, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient implanted bilaterally with multifocal Toric intraocular lenses (IOLs) experienced poor quality of vision, intolerable halos, and glare following implantation and was unable to drive at night. Visual symptoms were first identified during post-operative examinations. Pre-operative BSCVA was reported as 20/25 in the right eye and 20/20 in the left eye, while post-operative BSCVA was 20/20 in both eyes. Due to difficulty adapting to the lenses, the lenses in both eyes were explanted. The replacement lenses were non-Johnson & Johnson lenses with a power of 17.0 diopters. No capsule tear occurred, and no unplanned medical or surgical interventions, including vitrectomy, incision enlargement, sutures, or medications outside the standard of care, were required. No pre-existing conditions were reported. The patient outcome was reported as doing well following surgery; however, the patient still requires lens adjustment with Praxis. The customer indicated that the directions for use were followed. No further information was provided.This report pertains to the patient's right eye. A separate report is being submitted to document the event associated with the pa

  Patient problems: Halo; Visual Disturbances

  MAUDE report 50105479 ↗
• InjuryFeb 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING IMPLANTATION OF A PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL), MODEL DRT225, IN THE PATIENT¿S LEFT EYE, THE PATIENT EXPERIENCED BLURRY VISION AND POOR NIGHT VISION. THE PATIENT REPORTED AN INABILITY TO PERFORM NIGHT-DRIVING ACTIVITIES THAT SHE HAD BEEN ABLE TO DO PRIOR TO SURGERY. THE LENS WAS SUBSEQUENTLY EXPLANTED DURING A SECONDARY SURGICAL PROCEDURE WITH A NON¿JOHNSON & JOHNSON LENS. NO INCISION ENLARGEMENT, VITRECTOMY, SUTURES, OR PROCEDURAL DELAYS WERE REQUIRED. THE PATIENT¿S BEST-CORRECTED VISUAL ACUITY REMAINED 20/20 BOTH PRE- AND POST-OPERATIVELY. DIRECTIONS FOR USE WERE CONFIRMED TO HAVE BEEN FOLLOWED. INITIALLY IT WAS REPORTED THAT PREOPERATIVE REFRACTION: -0.75 -0.75 × 65, TARGET REFRACTION: -0.07 AND POSTOPERATIVE REFRACTION: PLANO SPHERE. HOWEVER, DURING A FOLLOW-UP THEY REPORTED THAT PREOPERATIVE REFRACTION: -1.25 +0.50 × 64, POSTOPERATIVE REFRACTION: +1.00 -0.50 × 145 AND TARGET REFRACTION: PLANO. POSTOPERATIVE REFRACTION WITH THE NEW LENS HAS NOT YET BEEN MEASURED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 24283108 ↗