TECNIS ODYSSEY IOL DRN00V (REF DRN00V0275)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474810914), received between Feb 27, 2026 and Aug 27, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Scratched Material” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2026Scratched Material

  It was reported that a preloaded multifocal intraocular lens (IOL) was observed to have a dark marking near the edge of the lens. Despite the observed marking, the lens was successfully implanted, and no patient concerns were reported. The lens remains implanted. Additional information received indicated that the issue was not related to use error, as no resistance was encountered and no excessive force was applied during lens delivery. No patient injury was reported, and no unplanned medical or surgical interventions, such as vitrectomy, incision enlargement, or sutures were required. The physician indicated that the device did not cause or contribute to the event. No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50479074 ↗
• InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO HAD BEEN IMPLANTED WITH A PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) IN THE RIGHT EYE, EXPERIENCED HALOS AND DIFFICULTY DRIVING AT NIGHT. IT IS UNKNOWN IF THE ISSUE IMPACTED PATIENT'S DAILY ACTIVITIES. A POST-OPERATIVE EXAMINATION CONCLUDED THAT THE LENS REQUIRED EXPLANTATION, AND IT WAS REPLACED WITH A NON-JOHNSON & JOHNSON LENS OF +26.0 DIOPTER DURING A SECONDARY SURGERY. THE PROCEDURE WAS COMPLETED WITHOUT UNPLANNED INCISION ENLARGEMENT, UNPLANNED SUTURES, UNPLANNED VITRECTOMY, OR PROCEDURAL DELAYS. NO ADDITIONAL MEDICAL ATTENTION OR MEDICATION BEYOND STANDARD CARE WAS REQUIRED, AND THE DIRECTIONS FOR USE WERE FOLLOWED. THE PRE AND POST OPERATIVE BSCVA (BEST SPECTACLE CORRECTED VISUAL ACUITY) WERE 20/20 AND 20/20-1. THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo

  MAUDE report 24477086 ↗