TECNIS ODYSSEY TORIC II IOL DRT150 (REF DRT1500175)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474811300), received between Jul 23, 2025 and Jul 31, 2026 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 5 most recent of 5 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 multifocal toric intraocular lens (IOL) was explanted from the patient's right eye due to suboptimal vision. Prior to explantation, the patient experienced difficulty with both distance and near vision and was unable to drive at night due to halos. The patient experienced a loss of two or more lines of best spectacle-corrected visual acuity (BSCVA), decreasing from a preoperative BSCVA of 20/25 to a postoperative BSCVA of 20/40. Preoperative refraction was reported as -2.75 +1.25 x 180, and postoperative refraction was -1.50 sphere, with an intended target refraction of plano. The patient was not reported to be over-corrected or under-corrected. A history of previous LASIK surgery was reported. The lens was replaced with a non-Johnson & Johnson lens of lower diopter power (17.0D). No patient injury, such as a capsule tear, was reported. No medical intervention, including vitrectomy, sutures, incision enlargement, or medications outside the standard of care, was required, and no planned surgical interventions were reported. The procedure was completed successfully, and the patient was reported to be doing well. The customer indicated that the device did not ca

  Patient problems: Halo; Visual Impairment

  MAUDE report 50104691 ↗
• MalfunctionDec 16, 2025Break; Break

  IT WAS REPORTED THAT AFTER THE PRELOADED MULTIFOCAL TORIC INTRAOCULAR LENS (IOL) WAS FULLY IMPLANTED IN THE PATIENT'S LEFT EYE, THE IOL WAS FOUND TO HAVE A CRACK IN THE CENTER. THE LENS WAS THEN REMOVED AND REPLACED WITH ANOTHER LENS OF THE SAME MODEL AND DIOPTER. THERE WAS AN EXTRA 5 MINUTE DELAY IN PROCEDURE. THERE WAS NO UNPLANNED SUTURE REQUIRED. IT IS UNKNOWN IF THERE WAS AN INCISION ENLARGEMENT. THE ISSUE DID NOT AFFECT PATIENT'S DAILY ACTIVITIES AND THE PATIENT DID NOT SEEK MEDICAL ATTENTION OR WAS NOT PRESCRIBED WITH MEDICATION OUTSIDE OF STANDARD OF CARE. THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23824320 ↗
• InjurySep 15, 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 EXPERIENCING SEVERE GLARE, HALOS, AND POOR-QUALITY VISION FOLLOWING THE IMPLANTATION OF THE LENS. THE SYMPTOMS WERE DESCRIBED AS VERY SEVERE AND DEBILITATING, IMPACTING THE PATIENT'S ABILITY TO PERFORM ACTIVITIES. THE LENS WAS EXPLANTED AND REPLACED WITH AN UNKNOWN EYHANCE LENS. THERE WAS NO CAPSULE TEAR, UNPLANNED VITRECTOMY, OR USE OF SUTURES REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 23058985 ↗
• InjuryAug 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TECNIS ODYSSEY SIMPLICITY 17.5 D INTRAOCULAR LENS (IOL) ON (B)(6) 2025 IN THE RIGHT EYE (OD) REPORTED DIFFICULTY READING AND SOME MILD BLURRED VISION AT DISTANCE. THE LENS WAS EXPLANTED DURING SECONDARY SURGERY ON (B)(6) 2025 AND REPLACED WITH SAME MODEL 18 D IOL. THE PROCEDURE DID NOT REQUIRE UNPLANNED INCISION ENLARGEMENT, SUTURES, OR VITRECTOMY, AND THERE WAS NO PROCEDURAL DELAY. THE PATIENT¿S PRE-OPERATIVE BEST CORRECTED VISUAL ACUITY WAS 20/25, AND POST-OPERATIVE VISUAL ACUITY IMPROVED TO 20/20. THE PATIENT WAS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 22913483 ↗
• MalfunctionJul 23, 2025Break; Device Difficult to Setup or Prepare; Ejection Problem; Break; Device Difficult to Setup or Prepare; Ejection Problem

  IT WAS REPORTED THAT THE LEADING HAPTIC ON THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS INVERTED AND EXCESSIVE RESISTANCE WAS FELT WHEN ADVANCING THE IOL. THE DOCTOR NOTICED THE INVERTED HAPTIC UNDER A MICROSCOPE. THERE WAS NO CONTACT WITH THE PRELOADED DEVICE OR IOL. THE PROCEDURE WAS COMPLETED WITH A BACKUP LENS. THERE WERE NO COMPLICATIONS SUCH AS A CAPSULE TEAR, VITRECTOMY OR SUTURES. REPORTEDLY, THE DIRECTIONS FOR USE WERE FOLLOWED. THE PATIENT IS DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22581056 ↗