TECNIS ODYSSEY IOL DRN00V (REF DRN00V0140)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474810648), received between Dec 31, 2024 and Jul 21, 2026 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (3 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.

• MalfunctionJul 21, 2026Scratched Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25893860 ↗
• MalfunctionJun 12, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE CUSTOMER REPORTED AN ISSUE WITH AN INTRAOCULAR LENS (IOL) THAT BECAME TILTED IN THE PATIENT'S OPERATIVE EYE. THE DOCTOR ATTEMPTED TO REPOSITION THE LENS BUT INDICATED THAT REMOVAL MIGHT POTENTIALLY BE NECESSARY. THE DOCTOR ATTRIBUTED THE ISSUE TO THE SIZE OF THE PATIENT'S EYE, RATHER THAN ANY DEFECT IN THE ODYSSEY DEVICE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

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

  MAUDE report 22191453 ↗
• MalfunctionJun 4, 2025Scratched Material; Scratched Material

  IT WAS REPORTED THAT A PRELOADED LENS WAS INSERTED INTO THE EYE, AND THE SURGEON NOTICED A SCRATCH ON THE IOL AFTERWARD. THE LENS WAS CUT OUT, AND A NEW LENS WAS PLACED. ADDITIONAL INFORMATION REVEALED THAT THE OPTIC WAS DAMAGED, AND THE BACKUP LENS WAS PLACED WITHOUT ISSUE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22146553 ↗
• MalfunctionFeb 23, 2025Scratched Material; Scratched Material

  THE DOCTOR NOTICED INDENTATIONS ON THE OPTIC OF THE PRE-LOADED DRN00V MODEL INTRAOCULAR LENS (IOL). THE SURGERY WAS COMPLETED IN THE SAME PROCEDURE AND THERE WAS NO PATIENT INJURY. IT WAS STATED DAMAGED PRODUCT RECEIVED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21442748 ↗
• InjuryDec 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) EXPLANTED FROM PATIENT'S RIGHT EYE AS THE PATIENT WAS NOT HAPPY WITH VISION EXPERIENCING VISUAL ISSUES, INCLUDING HALOS AND BLURRINESS. THE ISSUE WAS IDENTIFIED DURING POST-OP EXAM AND THE PATIENT SOUGHT MEDICAL ATTENTION DUE TO THE COMPLICATIONS. THE LENS WAS EXPLANTED IN THE SECONDARY PROCEDURE AND REPLACED WITH ZCB00 WITH 15.0 DIOPTER. THE BEST CORRECTED VISUAL ACUITY BSCVA) PRE-OPERATIVE WAS 20/60. THE PATIENT HAD FULLY RECOVERED. THERE WAS NO PATIENT INJURY. THERE WAS NO MEDICAL/SURGICAL INTERVENTION REQUIRED. FROM ADDITIONAL INFORMATION IT WAS LEARNT THAT THERE WAS NO PRODUCT ISSUE. THERE WAS NO CALCULATION ISSUE. THERE WAS NO USE ERROR. THE PATIENT FEEL BETTER WITH REPLACED LENS. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Discomfort; Halo

  MAUDE report 21048614 ↗