TECNIS ODYSSEY IOL DRN00V (REF DRN00V0110)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474810587), received between Apr 1, 2025 and Jul 16, 2026 — classified as 2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S LEFT EYE DUE TO DYSPHOTOPSIA, INCLUDING HALOS AND GLARE. NO PATIENT OR USER HARM REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 25849503 ↗
• MalfunctionJan 12, 2026Operating System Becomes Nonfunctional; Scratched Material

  IT WAS REPORTED THAT AFTER THE PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) WAS FULLY INSERTED INTO THE PATIENT'S RIGHT EYE, IT WAS NOTICED THAT THE IOL WAS SCRATCHED. IT WAS REPORTED THAT THE PLUNGER IMPACTED THE LENS DURING LOADING AND THE LENS WAS SCRATCHED WHEN IT WENT THROUGH THE INSERTER. THE LENS HAD TO BE REMOVED FROM THE EYE. THERE WAS NO PATIENT INJURY AND NO ADVERSE EVENTS. NO UNPLANNED SURGICAL INTERVENTIONS SUCH AS, INCISION ENLARGEMENT, SUTURES, OR VITRECTOMY WERE REQUIRED. THE DEVICE WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24032000 ↗
• MalfunctionJan 2, 2026Break; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT DURING THE IMPLANTATION OF THE PRELOADED INTRAOCULAR LENS (IOL), THE IOL WAS EXTRUDED IN AN EXCESSIVELY BENT CONFIGURATION. THEREFORE, THE IOL WAS NOT USED. THE ACCOUNT REPORTED RESISTANCE WHEN PUSHING OUT THE IOL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A REPLACEMENT DEVICE. NO PATIENT INJURY WAS REPORTED. NO OTHER MEDICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23946783 ↗
• InjuryApr 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DRN00V MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE). IN A SECONDARY SURGICAL PROCEDURE, THE IOL WAS EXPLANTED DUE TO COMPLAINTS OF BLURRY VISION - MECHANICAL COMPLICATION OF IOL AND REPLACED WITH A DCB00 IOL. THERE WAS NO MEDICAL INTERVENTION AND NO SURGICAL INTERVENTION DURING THE EXPLANT PROCEDURE. PATIENT PROGNOSIS POST LENS EXCHANGE WAS REPORTED AS SATISFACTORY WITHOUT ANY COMPLICATIONS POST-SURGERY. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 21749141 ↗