TECNIS ODYSSEY TORIC II IOL DRT150 (REF DRT1500130)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474811218), received between Jan 30, 2026 and Sep 21, 2026 — classified as 1 injury, 3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Unstable

  Patient problems: Visual Impairment

  MAUDE report 50845495 ↗
• MalfunctionJul 16, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25845218 ↗
• InjuryMar 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED MULTIFOCAL TORIC INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT¿S LEFT EYE DUE TO AN UNSPECIFIED VISUAL ISSUE. THE REPLACEMENT LENS WAS OF THE SAME MODEL. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE EXPLANTED INTRAOCULAR LENS WAS NOT PRESERVED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury; Visual Impairment

  MAUDE report 24570828 ↗
• MalfunctionJan 30, 2026Break

  IT WAS REPORTED THAT A PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL), MODEL DRT150, COULD NOT BE IMPLANTED. THE NURSE OBSERVED A CRACK IN THE LENS PERIPHERY, AND THE LENS WAS EXPLANTED. ADDITIONAL INFORMATION CONFIRMED THAT THE OPTIC WAS DAMAGED. THE CARTRIDGE AND LENS MADE CONTACT WITH THE PATIENT¿S RIGHT EYE DURING THE PROCESS. THE ORIGINAL LENS WAS EXPLANTED AND REPLACED WITH A BACKUP LENS OF THE SAME MODEL AND DIOPTER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT INJURY WAS REPORTED; HOWEVER, THE PATIENT EXPERIENCED A LONGER RECOVERY PERIOD DUE TO THE NEED FOR LENS EXPLANTATION, INCLUDING CORNEAL EDEMA WHICH RESOLVED APPROXIMATELY 14 DAYS POST-PROCEDURE. NO VITRECTOMY OR SUTURES WERE REQUIRED, THOUGH THE INCISION WAS MILDLY ENLARGED TO ACCOMMODATE THE EXPLANT. THE DEVICE WAS DETERMINED TO HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE PATIENT¿S CURRENT OUTCOME IS STABLE, WITH 20/25 UNCORRECTED DISTANCE VISUAL ACUITY AND JAEGER 1+ NEAR ACUITY AT TWO WEEKS POST-OPERATIVE. THE COMPLAINT DEVICE WAS DISCARDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 24224014 ↗