TECNIS ODYSSEY TORIC II IOL DRT225 (REF DRT2250205)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05050474811959), received between Oct 30, 2024 and Feb 26, 2026 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PREOPERATIVELY PATIENT¿S RIGHT EYE (OD) HAD A REFRACTION OF -1.00+2.00×167 WITH A BSCVA OF 20/25-2 AND THE INTENDED TARGET REFRACTION WAS PLANO. PATIENT HAD CLEAR LENS EXCHANGE AND A PRELOADED TORIC IOL WAS IMPLANTED. AFTER THAT INITIAL IMPLANTATION THE POSTOPERATIVE REFRACTION MEASURED -0.25 SPHERE WITH A BSCVA OF20/30, BUT THE PATIENT REPORTED PERSISTENT BLURRY VISION THAT NEVER IMPROVED AND INTERFERED WITH DAILY ACTIVITIES SUCH AS DRIVING. BECAUSE THE VISUAL DISTURBANCE PERSISTED AND THE PATIENT HAD LOST TWO OR MORE LINES OF BSCVA (DESPITE NOT BEING OVERCORRECTED OR UNDERCORRECTED), THE TORIC IOL WAS EXPLANTED AND REPLACED WITH A DIFFERENT, NON¿JOHNSON & JOHNSON LENS. FOLLOWING THE LENS EXCHANGE THE POSTOPERATIVE REFRACTION WAS-0.75+0.50×120AND THE PATIENT REPORTED BETTER VISION. THE EXPLANTED LENS WAS DISCARDED AND UNAVAILABLE FOR RETURN. NO PREEXISTING CONDITIONS AFFECTING LENS CALCULATION WERE NOTED, NO UNPLANNED INTRAOPERATIVE INTERVENTIONS (SUCH AS VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES) WERE REQUIRED, NO ADDITIONAL MEDICATIONS BEYOND STANDARD OF CARE WERE USED, NO FURTHER SURGICAL PROCEDURES WERE PLANNED, AND NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 24465143 ↗
• InjuryFeb 24, 2026Adverse Event Without Identified Device or Use Problem

  THE DRT225 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S EYE. POST-OPERATIVELY, PATIENT REPORTS POSITIVE DYSPHOTOPSIA AND POOR QUALITY OF VISION DESPITE PLANO REFRACTION. AN IOL EXCHANGE WAS SCHEDULED FOR (B)(6) 2026 HOWEVER, THERE WAS NO CONFIRMATION THE IOL EXPLANT OCCURRED. THE SUSPECT IOL WAS RETURNED FOR PRODUCT INVESTIGATION, THUS INDICATING THE IOL WAS EXPLANTED DURING A SECONDARY SURGICAL PROCEDURE. BOTH REPLACEMENT LENS INFORMATION AND PATIENT PROGNOSIS POST LENS EXCHANGE ARE UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Flashers

  MAUDE report 24438731 ↗
• InjuryDec 23, 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 BOTH RIGHT EYE AND LEFT EYE. AFTER THE IMPLANT IT WAS REPORTED THAT THE PATIENT EXPERIENCED PERFECT REFRACTIVE RESULT BUT SEVERE DYSPHOTOPSIA IN BOTH EYES THAT DID NOT IMPROVE OVER 3 MONTHS. THE IOLS WERE EXCHANGED. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR THE LEFT EYE. MANUFACTURER REPORT NUMBER 3012236936-2025-0003435. THE RIGHT EYE IS BEING REPORTED IN MANUFACTURER REPORT NUMBER 3012236936-2025-0003437.

  Patient problems: Visual Disturbances

  MAUDE report 23885796 ↗
• InjuryDec 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PRELOADED MULTIFOCAL TORIC INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S LEFT EYE, AND A PRELOADED MULTIFOCAL IOL WAS IMPLANTED IN THE RIGHT EYE. POSTOPERATIVELY, THE PATIENT EXPERIENCED BLURRY VISION AT BOTH NEAR AND DISTANCE THAT DID NOT IMPROVE WITH REFRACTION. THE PATIENT STATED THAT SHE USED TO BE ABLE TO SIT ON HER COUCH AND READ BUT IS NO LONGER ABLE TO DO SO AFTER THE SURGERY. SHE IS UNHAPPY WITH DISTANCE VISION WITH HER MULTIFOCAL IOLS AND HAS TRIED THEM FOR ONE YEAR WITHOUT SUCCESS. PRE-OPERATIVE REFRACTION WAS: MANIFEST REFRACTION (MR) DRY, RIGHT EYE (OD) -1.25 +0.75 020 AND LEFT EYE (OS) +0.50 +0.75 107. POST-OPERATIVE REFRACTION WAS D -1.00 +0.25 030 "FUZZY" 20/25 HAND MOTION (HM) AND OS -0.50+1.00 180 "STILL BLURRY" 20/25 HM. TARGET WAS OD - 0.39 AND OS: -0.20. NO MEDICATION OUTSIDE STANDARD OF CARE REQUIRED. THE LENSES REMAIN IMPLANTED TO DATE AND THE EXPLANT HAS NOT BEEN SCHEDULED YET. NO FURTHER INFORMATION WAS PROVIDED. THE PATIENT HAD BILATERAL LENS IMPLANTATION. THIS REPORT IS FOR THE PATIENT'S LEFT EYE. A SEPARATE REPORT WILL BE SUBMITTED FOR THE RIGHT EYE.

  Patient problems: Blurred Vision

  MAUDE report 23874415 ↗
• InjuryJan 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE TORIC INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO UNKNOWN REASONS. THE LENS WAS REMOVED AND REPLACED WITH A NON-JNJ LENS IN A SECONDARY SURGICAL PROCEDURE. THERE WERE NO PATIENT INJURIES. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 21087047 ↗
• InjuryOct 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE TORIC LENS HAD BEEN EXPLANTED DUE TO GLARE AND HALOS AFFECTING NIGHT VISION, ESPECIALLY WHILE DRIVING. THE PATIENT UNDERWENT AN IOL EXCHANGE AND ANOTHER MONOFOCAL J&J LENS WAS SUCCESSFULLY IMPLANTED WITH NO FURTHER COMPLICATIONS. POST-IMPLANTATION, THE PATIENT IS VERY PLEASED WITH THE OUTCOME. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury; Halo; Visual Disturbances

  MAUDE report 20574299 ↗