TECNIS ODYSSEY TORIC II IOL DRT150 (REF DRT1500220)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 05050474811393), received between Nov 19, 2024 and Apr 16, 2026 — classified as 9 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 16, 2026Mechanical Jam; Scratched Material

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) HAD A LOADING ISSUE. IT WAS NOT NOTICED UNTIL THE IOL WAS IMPLANTED THAT IT HAD A SCRATCH ACROSS THE OPTIC SURFACE. THE IOL WAS CUT OUT OF THE EYE AND REPLACED WITH ANOTHER LENS OF THE SAME MODEL AND DIOPTER. THERE WERE NO MEDICAL OR SURGICAL INTERVENTIONS SUCH AS AN INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES. AND THERE ARE NO PLANS FOR AN INTERVENTION IN THE FUTURE. REPORTEDLY THE PATIENT HAS NO COMPLAINTS AND IS DOING ¿FINE¿. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24897364 ↗
• InjuryApr 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL), MODEL DRT150, WAS EXPLANTED FROM THE PATIENT¿S RIGHT EYE FOR AN UNKNOWN REASON. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH IMPLANTATION OF A REPLACEMENT LENS OF THE SAME MODEL (DRT150, +21.0 D), WITH A 1.0-DIOPTER DIFFERENCE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 24793383 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  A PLANNED EXPLANT OF A PRELOADED MULTIFOCAL TORIC INTRAOCULAR LENS (IOL) WAS INITIALLY REPORTED DUE TO HALOS AND GLARE, THAT THE LENS IS CAUSING SIGNIFICANT HALO EFFECTS FOLLOWING ITS IMPLANTATION. PRE OP REFRACTION: +0.75 +1.25 X160, POST OP REFRACTION -1.00 +0.50 X030, TARGET FOR THE ORIGINAL IMPLANTED LENS TARGET- PLANO. THROUGH FOLLOW UPS, IT WAS LEARNED THAT THE EXPLANT WAS PERFORMED ON (B)(6) 2026. THE REPLACEMENT LENS IMPLANTED WAS OF DIFFERENT MODEL AND DIOPTER (ZCU150 21.5D). NO UNPLANNED SURGICAL INTERVENTIONS REQUIRED, NO MEDICATION OUTSIDE THE STANDARD OF CARE WAS PRESCRIBED AND NO PATIENT INJURY OR USER HARM REPORTED. THE PATIENT'S CURRENT OUTCOME STATUS POST EXPLANT REPORTED AS THE PATIENT IS DOING WELL. THE LENS IS NOT AVAILABLE FOR RETURNED AS IT WAS DISCARDED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 24736612 ↗
• MalfunctionNov 21, 2025Break; Contamination; Device Difficult to Setup or Prepare; Break; Contamination; Device Difficult to Setup or Prepare

  THE DRT150 MODEL INTRAOCULAR LENS (IOL) WAS INJECTED AND THE DOCTOR REPORTED THE FOLLOWING: THERE WAS A LITTLE MORE FRICTION THAN NORMAL, TWO (02) OPTICAL ABNORMALITIES, AND THERE WAS AN ADDITIONAL PIECE OF PLASTIC OR LENS MATERIAL THAT APPEARED TO COME OUT. THE IOL WAS REMOVED/EXPLANTED DURING THE SAME PROCEDURE AND ANOTHER ODYSSEY IOL WAS IMPLANTED IN THE PATIENT'S EYE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23619653 ↗
• InjurySep 7, 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 EXPLANTED. THE EXPLANT OCCURRED BECAUSE THE PATIENT EXPERIENCED POSTOPERATIVE POOR VISION (20/60) AND DID NOT DO WELL WITH THE MULTIFOCAL LENS. THE DOCTOR DECIDED TO EXCHANGE IT FOR A MONOFOCAL BAUSCH AND LOMB INTRAOCULAR LENS. THERE WAS NO PATIENT INJURY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 22989584 ↗
• InjuryJun 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S EYE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 22207207 ↗
• InjuryMay 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE LENS WAS EXPLANTED DUE TO THE PATIENT COMPLAINING OF BLURRY DISTANCE VISION, SEEING HALOS, AND FOGGINESS WITH A MYOPIC MISS OF -0.67 D. THE LENS WAS REMOVED AND REPLACED DURING A SECONDARY SURGICAL PROCEDURE WITH A NON-J&J LENS. THERE WAS NO INJURY AND NO FURTHER INTERVENTION WAS REQUIRED. THE PATIENT FULLY RECOVERED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Halo; Visual Disturbances; Visual Impairment

  MAUDE report 22039733 ↗
• InjuryMay 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE CUSTOMER THAT A LENS WAS EXPLANTED DUE TO ISSUES EXPERIENCED BY THE PATIENT, INCLUDING GLARE, HALOS, AND BLURRY VISION FOLLOWING SURGERY. THE VISUAL ISSUES WERE OBSERVED STARTING ON (B)(6) 2025 AND THE LENS WAS REMOVED DURING A SECONDARY SURGERY WITH UNKNOWN IOL. THE PATIENT HAS FULLY RECOVERED AND DID NOT REQUIRE ANY ADDITIONAL MEDICAL ATTENTION BEYOND STANDARD CARE. THE BEST SPECTACLE-CORRECTED VISUAL ACUITY (BSCVA) WAS 20/30 PRE-OPERATIVELY AND 20/20 POST-OPERATIVELY. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 21973032 ↗
• InjuryApr 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS(IOL) WAS EXPLANTED FROM PATIENT'S RIGHT EYE AS THE PATIENT COMPLAINED OF FOGGING VISION AND THE DISTANT VISION WAS WORSE THAN THEIR NEAR VISION. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AND REPLACED WITH A LENS FROM ANOTHER MANUFACTURER. THE PATIENT FEELS BETTER AND SEEING BETTER. FROM ADDITIONAL INFORMATION IT WAS LEARNT THAT DRT150 LENS HAD CONTRIBUTED FOR FOGGING VISION AND DISTANT VISION. THE DAILY ACTIVITIES WERE AFFECTED. THE REPLACED LENS HAD SATISFIED/CORRECTED THE PATIENT¿S ISSUES (FOGGING VISION AND DISTANT VISION. THERE WERE NO DEBILITATING CONDITION IN PATIENT. THERE WAS NO PATIENT INJURY. THERE WAS NO MEDICAL/SURGICAL INTERVENTION REQUIRED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 21874781 ↗
• InjuryMar 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DRT150 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). DUE TO COMPLAINTS OF DISSATISFACTION WITH VISION QUALITY, THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE; REPLACEMENT IOL INFORMATION IS NOT AVAILABLE. THERE WAS NO INCISION ENLARGEMENT, NO MEDICAL ATTENTION, NO MEDICATION PRESCRIBED, NO PROCEDURAL DELAYS, NO SUTURES, AND NO VITRECTOMY DURING THE EXPLANT PROCEDURE. PATIENT¿S DAILY ACTIVITIES WERE NOT SIGNIFICANTLY AFFECTED AND HER STATUS POST LENS EXCHANGE WAS REPORTED AS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Discomfort

  MAUDE report 21543132 ↗
• InjuryNov 19, 2024Difficult to Fold, Unfold or Collapse; Ejection Problem; Physical Resistance/Sticking; Difficult to Fold, Unfold or Collapse; Ejection Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) HAD SUPER STICKY HAPTICS AND WERE HARD TO COME APART. WHEN THE IOL CAME OUT THE SURGEON REPORTED THAT THE LENS JUMPED OUT, IT BUMPED THE IRIS AND CAUSED A LITTLE BIT OF BLEEDING IN THE EYE WHICH HE EVENTUALLY ACHIEVED HEMOSTASIS AND THE BLEEDING STOPPED. THE LENS UNFOLDED CORRECTLY AFTER THE HAPTICS WERE PULLED APART. UNSURE IF THE HAPTICS WERE STUCK TO EACH OTHER OR THE OPTIC. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Choroidal Hemorrhage

  MAUDE report 20720454 ↗