TECNIS ODYSSEY TORIC II IOL DRT150 (REF DRT1500170)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474811294), received between Feb 21, 2025 and Sep 18, 2026 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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.

• MalfunctionSep 18, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50822390 ↗
• MalfunctionNov 25, 2025Break; Break

  IT WAS REPORTED THAT THE PRELOADED MULTIFOCAL TORIC INTRAOCULAR LENS (IOL) WAS FULLY INSERTED AND THEN REMOVED AND REPLACED IN THE SAME PROCEDURE DUE TO THE LENS BEING CRACKED. THE PROCEDURE WAS COMPLETED USING ANOTHER JOHNSON AND JOHNSON IOL OF THE SAME MODEL AND DIOPTER. NO MEDICAL INTERVENTION, SUCH AS VITRECTOMY, SUTURES, OR INCISION ENLARGEMENT, WAS REQUIRED. THERE WAS NO PATIENT INJURY. THE PATIENT IS DOING WELL POST-SURGERY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23653113 ↗
• MalfunctionNov 25, 2025Break; Break

  IT WAS REPORTED THAT THE PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL), MODEL DRT150, WAS FOUND TO BE DEFECTIVE AND SUBSEQUENTLY DISCARDED. THE EXTENT OF PATIENT CONTACT IS UNKNOWN/NOT PROVIDED. NO FURTHER INFORMATION WAS PROVIDED. THE ISSUE WAS REPORTED WITH TWO LENSES. THIS REPORT CORRESPONDING TO THE PRODUCT (DRT150, SN (B)(6)). A SEPARATE REPORT WILL BE SUBMITTED FOR THE OTHER LENS (DRT150, SN (B)(6)).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23653074 ↗
• MalfunctionJul 18, 2025Break; Break

  IT WAS REPORTED THAT THE TORIC INTRAOCULAR LENS (IOL) WAS DELIVERED FROM THE CARTRIDGE WITH A CRACK FROM THE PERIPHERY GOING INWARD. IOL WAS CUT AND REMOVED FROM EYE. LOADING TECHNIQUE WAS APPROPRIATE, ADVANCING IOL IN FOLDED POSITION AND TUNNEL REPORTED NO RESISTANCE. VISCOELASTIC WAS USED AND THE DWELL TIME DURING THE DEVICE PREPARATION WAS APPROXIMATELY ONE MINUTE. NO MANIPULATION WAS REQUIRED TO DEPLOY THE DEVICE. SURGERY WAS COMPLETED IN SAME PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22549898 ↗
• InjuryFeb 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MULTIFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT'S RIGHT EYE BECAUSE OF SPECIFIC VISUAL ISSUES. THE PATIENT REPORTED THAT NEAR, INTERMEDIATE, AND NIGHT VISION WERE BLURRY AND FUZZY. A NON-JOHNSON & JOHNSON LENS WAS USED AS A REPLACEMENT (THE DIOPTER OF REPLACEMENT LENS WAS NOT PROVIDED). NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTIONS SUCH AS VITRECTOMY, SUTURES, OR INCISION ENLARGEMENT WAS REQUIRED. THERE WAS NO PATIENT INJURY REPORTED. IT WAS INDICATED THAT THE PATIENT IS DOING BETTER, IMPROVED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 21434937 ↗