TECNIS ODYSSEY TORIC II IOL DRT225 (REF DRT2250210)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474811966), received between Dec 30, 2024 and Jun 1, 2026 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MULTIFOCAL TORIC INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT'S RIGHT EYE DUE TO THE PATIENT EXPERIENCING BLURRY VISION. THERE WAS NO REPORTED HARM TO THE PATIENT OR USER. THE PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 25355481 ↗
• InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S EYE. HOWEVER, THE PATIENT SEEMED TO NEED A STRONGER DIOPTER OF THE SAME LENS. THE ISSUE WAS NOTED DURING AN OFFICE VISIT 1 MONTH POST-OPERATIVELY. THE SYMPTOMS WERE NOT DEBILITATING. THE IOL WAS SUBSEQUENTLY EXPLANTED DUE. THE EXPLANTED IOL MODEL DRT225 AND 21.0 DIOPTER WAS REPLACED WITH THE SAME MODEL DRT225 BUT 21.5 DIOPTER. REPORTEDLY, THE PATIENT IS DOING WELL.

  Patient problems: Visual Impairment

  MAUDE report 23994364 ↗
• InjuryNov 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse 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. THE PATIENT EXPERIENCED GLARE AND HALOS THAT SIGNIFICANTLY AFFECTED THEIR DAILY ACTIVITIES AND EXPRESSED A DESIRE TO TRY A LENS WITH LESS GLARE. THE IOL WAS EXPLANTED THE REPLACEMENT LENS IS UNKNOWN. THERE WAS NO INCISION ENLARGEMENT AND NO VITRECTOMY. THE MEDICATION PRESCRIBE WAS WITHIN THE STANDARD OF CARE. THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 23493557 ↗
• InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ABOUT ONE WEEK AFTER THE PRELOADED TORIC INTRAOCULAR LENS WAS IMPLANTED, THE PATIENT'S DISTANT VISUAL ACUITY DIDN'T IMPROVED MUCH. THE DISTANCE VISUAL ACUITY WAS 0.6 WITH THE NAKED EYE AND NEAR VISUAL ACUITY WAS 40 CM WITH 0.2. THE PATIENT DID NOT PRESENT WITH ANY CORNEAL ABNORMALITY OR FUNDUS DISEASE. THE PATIENT IS UNDER OBSERVATION, BUT THE IMPLANTATION OF A LENS FROM A DIFFERENT MANUFACTURER IS BEING CONSIDERED. THERE WERE NO PATIENT INJURIES, AND NO OTHER MEDICAL INTERVENTION WAS REQUIRED. THROUGH FOLLOW-UP WE LEARNED, THAT THE LENS WAS EXPLANTED ON (B)(6) 2024 AND THE INCISION WAS ENLARGED. A LENS FROM A DIFFERENT MANUFACTURER WAS IMPLANTED. THE PREOPERATIVE UNCORRECTED VISUAL ACUITY WAS 0.3 AND THE CORRECTED VISUAL ACUITY WAS 0.8. THE POSTOPERATIVE UNCORRECTED VISUAL ACUITY WAS 0.6 AND THE CORRECTED VISUAL ACUITY IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 21044607 ↗