TECNIS ODYSSEY TORIC II IOL DRT150 (REF DRT1500200)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 05050474811355), received between Nov 11, 2024 and Aug 25, 2026 — classified as 8 injuries, 3 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryAug 25, 2026Adverse 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 symptoms which details were not provided. The symptoms were reported as debilitating due to the effect it had on the patient¿s driving. The IOL was explanted and replaced with another Johnson and Johnson lens model DEN00V 21.0 diopter. There was no capsule tear, vitrectomy, incision enlargement or sutures. The patient¿s pre-operative uncorrected and best corrected visual acuity was reported as 20/25 -2 and post-operative. No further information was provided.

  Patient problems: Eye Injury

  MAUDE report 50436682 ↗
• InjuryAug 14, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that the preloaded Johnson and Johnson (JnJ) Intraocular lens (IOL) was implanted into the patient's right eye. The customer reported that there was a mistake in the lens power chosen for the patient. There was nothing wrong with the lens. The patient was unhappy with their vision. There were no complications such as a vitrectomy, incision enlargement or sutures. The IOL was explanted and replaced with another JnJ lens model DET150 20.5 diopter. The patient is doing well. No further information is available.

  Patient problems: Visual Impairment

  MAUDE report 50256402 ↗
• MalfunctionApr 23, 2026Scratched Material

  IT WAS REPORTED THAT, UPON INSERTION OF A PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL), MODEL DRT150, A SCRATCH WAS OBSERVED. THE LENS WAS SUBSEQUENTLY CUT, REMOVED, AND REPLACED. PATIENT CONTACT OCCURRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24975133 ↗
• InjuryApr 23, 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 LEFT EYE. THE PATIENT HAS ALLOWED SEVERAL MONTHS FOR THE ADAPTATION OF THE MULTIFOCAL LENS AND HAS ADAPTED SOMEWHAT. PATIENT FEELS THEIR VISION IS UNRELIABLE NECESSITATING SIGNIFICANT LIGHT TO SEE CLEARLY. DURING A POST-OPERATIVE EXAMINATION, THE PATIENT EXPRESSED ISSUE WITH THEIR VISION INCLUDING VISUAL DISTURBANCES, BLURRY VISION, AND HALOS OR GLARE. THE PATIENT FLIES PLANES OFTEN IN DARK LIGHT OR WITH RED LIGHTS ON THE INSTRUMENT PANEL. THE PATIENT PRIORITIZES CLEAR DISTANCE VISION AND USING READING GLASSES INSTEAD. THE PATIENT DOES NOT WANT TO BLEND HIS VISION MEANING MONOFOCAL AND MULTIFOCAL LENSES BECAUSE THIS MIX HAS BEEN DIFFICULT TO ADAPT TO AND MAKES HIM FEEL OFF. THE IOL WAS SUBSEQUENTLY EXPLANTED. NO HARM TO THE PATIENT OR USER HAS BEEN REPORTED IN CONNECTION WITH THIS COMPLAINT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 24975092 ↗
• InjuryApr 6, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT, DURING THE IMPLANTATION PROCEDURE, A HAPTIC OF THE PRELOADED MULTIFOCAL TORIC INTRAOCULAR LENS (IOL) ADHERED TO THE OPTIC, SUBSEQUENTLY OPENED, AND RESULTED IN A CAPSULAR RUPTURE. THE LENS WAS LEFT IN THE PATIENT¿S EYE BY THE PHYSICIAN, AND THE PATIENT WAS REFERRED TO A RETINA SURGEON. IT WAS NOTED THAT THE DEVICE DID CAUSE OR CONTRIBUTE TO THE EVENT AND THAT THE PATIENT DID NOT HAVE ANY PRE-EXISTING CONDITION. ON (B)(6) 2023, THE LENS WAS EXPLANTED BY A RETINA SURGEON AT A DIFFERENT SURGICAL CENTER, WHERE A VITRECTOMY WAS PERFORMED. THE REPLACEMENT LENS INFORMATION IS UNKNOWN. THE EXPLANTING CENTER DID NOT RETAIN THE LENS FOR RETURN OR FURTHER INVESTIGATION. IT WAS NOTED THAT THE EVENT WAS ASSOCIATED WITH REPORTED PATIENT HARM. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 24792180 ↗
• MalfunctionNov 18, 2025Break; Break

  IT WAS REPORTED THAT ONCE THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S EYE A CRACK WAS NOTICED ON THE OPTIC. THE IOL WAS LEFT IN THE EYE. THE AFFECTED AREA OF THE LENS WAS ROTATED TO BE UNDER THE SUPERIOR LID. THE DEVICE REMAINS IMPLANTED. THERE WERE NO COMPLICATIONS SUCH AS CAPSULE TEAR, VITRECTOMY INCISION ENLARGEMENT, OR SUTURES? THE PATIENT OUTCOME WAS REPORTED AS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23583894 ↗
• InjuryNov 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE IMPLANTATION OF THE PRELOADED MULTIFOCAL TORIC INTRAOCULAR LENS (IOL), THE PATIENT COMPLAINED OF THE INABILITY TO SEE MID-RANGE AND HALOS WHICH WERE MAKING IT CHALLENGING TO DRIVE AT NIGHT. THE ISSUE WAS IDENTIFIED DURING A POST-OPERATIVE EXAMINATION. THE LENS WAS SUBSEQUENTLY EXPLANTED DURING A SECONDARY SURGERY. THE PROCEDURE WAS COMPLETED WITHOUT ANY UNPLANNED COMPLICATIONS, SUCH AS INCISION ENLARGEMENT, SUTURES, OR VITRECTOMY. THERE WAS NO SURGICAL DELAY. NO MEDICAL ATTENTION OR MEDICATION OUTSIDE OF THE STANDARD OF CARE WAS REQUIRED. DIRECTIONS FOR USE WERE FOLLOWED. THE PATIENT¿S BEST SPECTACLE CORRECTED VISUAL ACUITY (BSCVA) WAS 20/20 PRE AND POST-OPERATIVELY. THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo

  MAUDE report 23512846 ↗
• InjurySep 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT CATARACT SURGERY INVOLVING THE IMPLANTATION OF AN ODYSSEY INTRAOCULAR LENS DRT150 20.0D. APPROXIMATELY ONE MONTH LATER, SHE REPORTED EXPERIENCING EDGE GLARE, WHICH WAS INITIALLY DESCRIBED AS VISION ISSUES, GLARE, AND HALOS. FOLLOWING THESE COMPLAINTS, IT WAS DECIDED TO EXPLANT THE LENS IN A SECONDARY PROCEDURE. THE LENS WAS SUCCESSFULLY EXPLANTED AND REPLACED WITH A BAUSCH & LOMB LI61 SILICONE LENS (NO COMPLICATIONS). NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 22979090 ↗
• MalfunctionAug 5, 2025Scratched Material; Scratched Material

  IT WAS REPORTED THAT AN ISSUE OCCURRED WITH A PRELOADED TECNIS TORIC ODYSSEY INTRAOCULAR LENS (IOL) DURING AN IMPLANTATION PROCEDURE. THE SURGEON IDENTIFIED A DEPRESSION MARK ON THE LENS OPTIC, WHICH LED TO THE LENS BEING CUT AND REMOVED. A BACKUP LENS WAS THEN SUCCESSFULLY IMPLANTED TO COMPLETE THE PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22719775 ↗
• InjuryApr 29, 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 BLURRY VISION AND PATIENT WAS NOT HAPPY WITH VISION, VISUAL ACUITY ONLY WENT DOWN TO 20/40, THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A NON-JOHNSON & JOHNSON IOL. THERE WAS NO MEDICAL INTERVENTION, NO PATIENT INJURY, AND NO SURGICAL INTERVENTION DURING THE LENS EXCHANGE PROCEDURE. PATIENT PROGNOSIS POST LENS EXCHANGE WAS REPORTED AS GREAT AND 20/30 VISUAL ACUITY ONE DAY POST-OP. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Discomfort

  MAUDE report 21931521 ↗
• InjuryNov 11, 2024Unstable; Unstable

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S RIGHT EYE BECAUSE THE IOL HAD ROTATED. AT THE TIME OF THIS REPORT THE DEGREE OF ROTATION WAS NOT PROVIDED. REPORTEDLY, THE DIRECTIONS FOR USE WERE FOLLOWED. THE IOL WAS REPLACED WITH A NON JNJ LENS 21.0 DIOPTER. THE PATIENT STATUS IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20660276 ↗