TECNIS ODYSSEY IOL DRN00V (REF DRN00V0125)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474810617), received between Sep 9, 2025 and Jan 12, 2026 — classified as 3 injuries.

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.

• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS SCHEDULED TO HAVE A PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) EXCHANGED FOR ANOTHER LENS. THROUGH FOLLOW UP, IT WAS CONFIRMED THAT THE IOL WAS EXPLANTED FROM THE LEFT EYE DUE TO THE PATIENT EXPERIENCING BOTHERSOME GLARE, HALOS, AND RINGS WHILE DRIVING AT NIGHT. THE LENS WAS REPLACED WITH A NON-JOHNSON AND JOHNSON MONOFOCAL IOL FOR DISTANCE TARGET. THE PATIENT WAS INITIALLY HAPPY WITH THE VISION WITH THE ORIGINAL LENS, WITH UNCORRECTED DISTANCE VISION OF 20/20 AND UNCORRECTED NEAR VISION OF J1+ BUT WAS BOTHERED BY THE VISUAL DISTURBANCES, THEREFORE, OPTED FOR THE IOL EXCHANGE. THE PATIENT NOTED IMPROVEMENT OF SYMPTOMS AFTER THE EXCHANGE TO THE MONOFOCAL. THE DEVICE WAS DISCARDED. NO FURTHER INFORMATION IS PROVIDED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 24032913 ↗
• InjuryDec 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PRELOADED MULTIFOCAL INTRAOCULAR LENSES (IOLS), MODEL DRN00V, WERE IMPLANTED BILATERALLY. POSTOPERATIVELY THE PATIENT ACHIEVED EXCELLENT VISUAL ACUITY BUT EXPERIENCED INTOLERABLE GLARE WITH ASSOCIATED HALOS, PROMPTING EXPLANTATION OF BOTH MULTIFOCAL IOLS DURING A SECONDARY PROCEDURE. EACH EYE WAS SUBSEQUENTLY IMPLANTED WITH A LIGHT ADJUSTABLE LENS. THE POSTOPERATIVE OUTCOME FOLLOWING THE EXCHANGE WAS NOT PROVIDED. NO PATIENT OR USER HARM WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED. THE PATIENT UNDERWENT BILATERAL INTRAOCULAR LENS IMPLANTATION. THIS REPORT PERTAINS TO THE LEFT EYE. A SEPARATE REPORT WILL BE SUBMITTED FOR THE RIGHT EYE.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 23812668 ↗
• InjurySep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PRELOADED INTRAOCULAR LENS WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE DURING SECONDARY SURGERY FOR AN UNKNOWN REASON AND WAS REPLACED WITH THE SAME MODEL OF A DIFFERENT DIOPTER LENS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 23009744 ↗