TECNIS ODYSSEY IOL DRN00V (REF DRN00V0265)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474810891), received between Sep 9, 2025 and Feb 17, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER IMPLANTATION OF A SINGLE-PIECE PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) IN THE PATIENT¿S LEFT EYE, THE PATIENT EXPERIENCED HALOS AND DIFFICULTIES DRIVING AT NIGHT. THE PATIENT DESCRIBED THESE SYMPTOMS AS BOTHERSOME. THE SYMPTOMS WERE NOTED DURING A POST-OP EXAM DURING A SITE VISIT. THE ORIGINAL LENS WAS SUBSEQUENTLY EXPLANTED DURING A SECONDARY SURGERY AND WAS REPLACED WITH A NON-JOHNSON & JOHNSON IOL WITH +25.5 DIOPTER. THE PRE-OPERATIVE BSCVA WAS 20/20-1, WHILE THE POST-OPERATIVE BSCVA WAS 20/20. NO UNPLANNED SURGICAL INTERVENTIONS, SUCH AS INCISION ENLARGEMENT, SUTURES, OR VITRECTOMY, WERE REQUIRED. NO MEDICATION WAS PRESCRIBED THAT WAS OUTSIDE OF THE STANDARD OF CARE. DIRECTIONS FOR USE WERE FOLLOWED. THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo

  MAUDE report 24370248 ↗
• InjuryDec 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S LEFT EYE. POSTOPERATIVELY THE PATIENT EXPERIENCED HALOS. THE PATIENT HAD A PRIOR HISTORY OF LASER-ASSISTED INTRASTROMAL KERATOMILEUSIS (LASIK). THE MULTIFOCAL IOL WAS SUBSEQUENTLY EXPLANTED DURING A SECONDARY PROCEDURE; NO UNPLANNED INCISION ENLARGEMENT, SUTURES, OR VITRECTOMY WERE REQUIRED, AND NO PROCEDURAL DELAYS WERE NOTED. THE LENS WAS REPLACED WITH A MONOFOCAL IOL, MODEL DIB00, 25.0 DIOPTER. THE PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo

  MAUDE report 23832590 ↗
• MalfunctionSep 9, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, A TEAR APPROXIMATELY 2 MM IN LENGTH WAS OBSERVED IN THE LENS, EXTENDING FROM THE PERIPHERY TO THE CENTER OF THE OPTICS. THE LENS WAS SUBSEQUENTLY REMOVED AND REPLACED WITH A BACKUP LENS OF THE SAME MODEL AND POWER DURING THE SAME PROCEDURE. THE PATIENT IS CURRENTLY DOING WELL. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23011373 ↗