TECNIS ODYSSEY IOL DRN00V (REF DRN00V0145)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474810655), received between Mar 29, 2024 and Mar 10, 2026 — classified as 4 injuries, 1 malfunction.

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.

• MalfunctionMar 10, 2026Break

  IT WAS REPORTED THAT A SINGLE PIECE PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) HAD A BROKEN HAPTIC. THE PATIENT CONTACT IS NOT YET KNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24555023 ↗
• InjuryFeb 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO VISUAL DISTURBANCES, SPECIFICALLY HALOS. THE LENS WAS NOT REMOVED ON THE SAME DAY IT WAS IMPLANTED. THE EXPLANTED LENS WAS REPLACED WITH A NON¿JOHNSON & JOHNSON LENS OF A DIFFERENT MODEL AND DIOPTER. NO PATIENT INJURY WAS REPORTED, AND NO ADDITIONAL SURGICAL OR MEDICAL INTERVENTIONS SUCH AS INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES WERE REQUIRED. THE PATIENT¿S OUTCOME WAS DESCRIBED AS FINE. THE LENS IS NOT AVAILABLE FOR RETURN, AS IT WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 24250970 ↗
• InjuryNov 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CLEAR LEANS EXCHANGE WAS PERFORMED AND THE DRN00V MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). DUE TO COMPLAINTS OF NIGHTTIME BLURRY VISION, THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A DCB00 14.5 IOL. PATIENT PROGNOSIS POST LENS EXCHANGE IS UNKNOWN. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 23479461 ↗
• InjuryApr 3, 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). POST-OPERATIVELY DUE TO PATIENT COMPLAINTS OF BLURRY NEAR VISION AND GLARE, THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A NON-JOHNSON & JOHNSON IOL, CCWTT0 14.5 DIOPTER LENS. THERE WAS NO INCISION ENLARGEMENT, NO MEDICAL ATTENTION, NO MEDICATION PRESCRIBED, NO PATIENT INJURY, NO PROCEDURAL DELAYS, NO SUTURES, AND NO VITRECTOMY DURING THE LENS EXCHANGE PROCEDURE. PATIENT'S VISION PRE-OPERATIVE WAS 20/80 AND POST-OPERATIVE WAS 20/20. THE PATIENT¿S DAILY ACTIVITIES WERE NOT SIGNIFICANTLY AFFECTED AND STATUS POST LENS EXCHANGE WAS REPORTED AS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 21769981 ↗
• InjuryMar 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE DUE TO "MECHANICAL FAILURE". THERE WAS NO PATIENT INJURY. AN INCISION ENLARGEMENT WAS REQUIRED. NO SUTURE OR VITRECTOMY WAS REQUIRED. AMVISC VISCOELASTIC WAS USED. THROUGH FOLLOW-UP, IT WAS CLARIFIED THAT "MECHANICAL FAILURE" MEANT THAT THE PATIENT WAS NOT SEEING CLEARLY AND DESCRIBED A "STROBE-LIKE" LIGHT SENSATION WITH VISION. ANOTHER JOHNSON AND JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (DIFFERENT MODEL, ZCB00 +14.5 DIOPTER). THE PATIENT'S PRE-OPERATIVE UNCORRECTED VISUAL ACUITY (VA) WAS 20/20 DISTANCE VISION, 20/60 NEAR VISION AND BEST CORRECTED VA WAS 20/20 DISTANCE VISION AND 20/60 NEAR VISION. THE PATIENT'S POST-OPERATIVE (POST-INITIAL IMPLANT) UNCORRECTED VA WAS 20/20 DISTANCE VISION, 20/60 NEAR VISION AND BEST CORRECTED VA 20/20 DISTANCE VISION AND 20/60 NEAR VISION. THE PATIENT'S POST-OPERATIVE (POST-REPLACEMENT IMPLANT) UNCORRECTED VA WAS 20/30-2 DISTANCE VISION AND 20/400 NEAR VISION AND BEST CORRECTED VA NOT AVAILABLE. THE TARGETED POST-OPERATIVE REFRACTION (FOR INITIAL IMPLANT) WAS EMMETROPIA, PLANO SPHERE. THERE WAS NO CALCULATION ISSUE. NO FURTHER INFORMATION WAS PROVI

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 19008900 ↗