TECNIS ODYSSEY TORIC II IOL DRT150 (REF DRT1500240)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474811430), received between Jan 30, 2025 and Aug 19, 2026 — classified as 3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 19, 2026Scratched Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50333946 ↗
• MalfunctionJan 13, 2026Break

  IT WAS REPORTED BY THE CUSTOMER THAT A PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL), MODEL DRT150, WAS RIPPED DURING AN ATTEMPT TO INSERT THE LENS. THE LENS DID NOT COME INTO CONTACT WITH THE PATIENT. THE PROCEDURE WAS COMPLETED USING A BACKUP LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24063489 ↗
• InjuryAug 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED LENS WAS EXPLANTED DUE TO BLURRED, HAZY VISION WITH GLARE. UNCORRECTED, THE PATIENT HAD A VISUAL ACUITY OF 20/30 WITH J5 NEAR VISION. THE PATIENT EXPERIENCED MINIMAL IMPROVEMENT WITH REFRACTION. AN EXCHANGE WAS PERFORMED FOR THE DIB00 LENS, WHICH WAS PREFERRED. NO INJURY OR INTERVENTION WAS REQUIRED. THE PATIENT FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 22757074 ↗
• InjuryJun 27, 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 EYE AS THE PATIENT EXPERIENCED HYPEROPIA AFTER ONE MONTH OF HAVING THE LENS +1.00 SP. THE PATIENT FIRST REPORTED BLURRY VISION IN THE LEFT EYE ON, STATING THERE WAS NO CLEAR FOCAL POINT, AND THAT +1.25 READERS HELPED FOCUS AT 10 FEET. THE PATIENT FELT NEED LENS EXCHANGE. THE PATIENT DID NOT SUSTAIN ANY INJURY, AND NO FURTHER MEDICAL OR SURGICAL INTERVENTIONS ARE ANTICIPATED. THE PATIENT'S PRE-OP UNCORRECTED AND BEST CORRECTED VISUAL ACUITY WAS 20/15 NV: 20/40 AND CC: 20/15 AND THE POST-OP UNCORRECTED AND BEST CORRECTED VISUAL ACUITY OS SC: 20/30-2 AND OS CC: 20/20. FROM ADDITIONAL INFORMATION IT WAS LEARNT THAT THE ISSUE WAS DUE TO CAPSULAR TRACTION AND LENS DESIGN. THE PATIENT WAS MORE DEPENDENT ON READERS TO SEE MORE CLEARLY UP CLOSE TO READ OR DO NEAR VISION ACTIVITIES. THE VISUAL ISSUE EXPERIENCED BY THE PATIENT WAS NEAR VISION LIMITATIONS. THERE WAS NO USE ERROR. THE PATIENT IS MUCH HAPPIER WITH EXCHANGE AS THERE IS MORE CLARITY AND CAN SEE BETTER UP CLOSE. THERE WAS NO PATIENT INJURY. ADEQUATE HEALING TIME WAS GIVEN TO PATIENT TO SEE IF THE PATIENT WOULD ADJUST AND TRIED OTC READERS. NO OTHER

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 22351939 ↗
• InjuryJan 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS NOT A GOOD CANDIDATE FOR ODYSSEY INTRAOCULAR LENS (IOL). PATIENT HAD OCULAR ISSUES NOT TOLD TO THE SURGEON. THE BAG WAS NOT STABLE ENOUGH. SECONDARY SURGICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Zonular Dehiscence

  MAUDE report 21280259 ↗