TECNIS ODYSSEY IOL DRN00V (REF DRN00V0180)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474810723), received between Mar 4, 2025 and Dec 29, 2025 — classified as 3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 29, 2025Break; Break

  DURING IMPLANTATION OF THE DRN00V MODEL INTRAOCULAR LENS (IOL), AN OPTIC DEFECT WAS NOTED. THE DOCTOR STATED THAT PATIENTS HAVE BEEN HAPPY WITH THEIR VISION, BUT HE CAN¿T HAVE THESE ISSUES. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23917464 ↗
• InjuryJun 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S EYE. THE PATIENT EXPERIENCED DYSPHOTOPSIAS. THE ISSUE WAS FIRST IDENTIFIED DURING A POST-OPERATIVE EXAM. THE CUSTOMER INDICATED THAT THE DIRECTIONS FOR USE WERE FOLLOWED. THERE IS NO INDICATION OF PERMANENT OR TEMPORARY IMPAIRMENT. THE IOL WAS EXPLANTED AND THE PATIENT WAS REPORTED AS DOING WELL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances; Visual Impairment

  MAUDE report 22333854 ↗
• MalfunctionApr 28, 2025Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL LENS WAS SCRATCHED AND THIS WAS NOTICED UPON INSERTION. ADDITIONAL INFORMATION SUGGESTS THAT A SCRATCH WAS OBSERVED ON THE IOL WHEN IT WAS INSERTED. THE LENS WAS FULLY INSERTED AND THEN REPLACED WITH ANOTHER J&J LENS DURING THE SAME PROCEDURE. THE PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21922923 ↗
• InjuryApr 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED A DRN00V (TECNIS ODYSSEY WITH SIMPLICITY DELIVERY SYSTEM INTRAOCULAR LENS {IOL}) WAS EXPLANTED DUE TO AN UNSPECIFIED ISSUE. THE LENS WAS REPLACED WITH A LIGHT ADJUSTABLE LENS (LAL) LENS. NO FURTHER INFORMATION WAS PROVIDED. NOTE: THIS REPORT PERTAINS TO PATIENT'S RIGHT EYE. ANOTHER REPORT WILL BE SUBMITTED FOR PATIENT'S LEFT EYE.

  Patient problems: Eye Injury

  MAUDE report 21875058 ↗
• InjuryMar 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S RIGHT EYE. THE PATIENT WAS ABLE TO SEE DISTANCE BUT CANNOT READ. THE ISSUE WAS NOTICED DURING A POST-OP EXAM. THE PATIENT ALSO EXPERIENCED DRY EYE AND BLURRED VISION. THEIR PRE-OPERATIVE VISION WAS RECORDED AS 20/30-2, BUT THE POST-OPERATIVE VISION STATUS IS UNKNOWN. THERE WERE NO COMPLICATION SUCH AS AN INCISION ENLARGEMENT, SUTURES, OR VITRECTOMY. THE PATIENT¿S STATUS WAS ALSO REPORTED AS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Dry Eye(s)

  MAUDE report 21521031 ↗