TECNIS ODYSSEY IOL DRN00V (REF DRN00V0135)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474810631), received between Mar 19, 2025 and Jun 18, 2026 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 18, 2026Break; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S EYE. THE PHYSICIAN ENCOUNTERED RESISTANCE WHEN ADVANCING THE PLUNGER. ACCOUNT INDICATED THAT THE DIRECTIONS FOR USE WERE FOLLOWED. DAMAGE OCCURRED TO THE TRAILING HAPTIC AND OPTIC OF THE IOL, REQUIRING THE INCISION TO BE ENLARGED FOR LENS REMOVAL. A BACKUP LENS WAS SUCCESSFULLY IMPLANTED WITHOUT ANY ISSUES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 25554717 ↗
• MalfunctionAug 1, 2025Device Difficult to Setup or Prepare; Scratched Material; Appropriate Device Problem Term/Code Not Available; Device Difficult to Setup or Prepare; Scratched Material; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING PRELOADED INTRAOCULAR LENS INSERTION, INITIAL ADVANCEMENT WAS DIFFICULT AND REQUIRED SLIGHTLY MORE FORCE THAN USUAL TO START, BUT IT BECAME EASIER ONCE THE LENS PROGRESSED THROUGH THE INSERTER. THERE WAS SOME DIFFICULTY DELIVERING THE LENS INTO THE EYE DUE TO A TIGHT THREAD MECHANISM. AFTER IMPLANTATION AND ASPIRATION/IRRIGATION TO REMOVE RESIDUAL CORTEX, A MARK ON THE LENS WAS OBSERVED ON THE RIGHT, WHICH WAS INITIALLY MISTAKEN FOR RESIDUAL CORTEX. NO MEDICAL OR SURGICAL INTERVENTIONS WERE REQUIRED, EXCEPT FOR THE POTENTIAL NEED FOR YAG (YTTRIUM ALUMINUM GARNET) LASER POSTERIOR CAPSULOTOMY IN THE FUTURE. THE PATIENT HAS THE IMPLANT IN THE EYE, WITH NO COMPLAINTS, AND IS DOING VERY WELL POST-OPERATIVELY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22687372 ↗
• 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 DEXTER (RIGHT 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 14.0 DIOPTER LENS. THERE WAS NO INCISION ENLARGEMENT, NO MEDICAL ATTENTION, NO PATIENT INJURY, NO SUTURES, AND NO VITRECTOMY DURING THE LENS EXCHANGE PROCEDURE. PATIENT'S VISION PRE-OPERATIVE WAS 20/150 AND POST-OPERATIVE WAS 20/25. 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 21770024 ↗
• InjuryMar 19, 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 RIGHT EYE. THE PATIENT EXPERIENCED BLURRY DISTANCE VISION. THE ISSUE WAS REPORTED BY THE PATIENT APPROXIMATELY FOUR POST-OPERATIVE VISITS OR 3-4 WEEKS AFTER SURGERY. BEST CORRECTED VISUAL ACUITY (BSCVA) PRE-OPERATIVE IS 20/20 AND BSCVA POST-OPERATIVE IS 20/20. THE IOL WAS EXPLANTED AND REPLACED WITH ANOTHER JOHNSON (JNJ) INTRAOCULAR LENS (IOL), SAME MODEL AND DIFFERENT DIOPTER, 13.0 DIOPTER. REPORTEDLY, THERE WAS NO INCISION ENLARGEMENT OR SUTURES REQUIRED. THE PATIENT IS DOING ¿OK¿. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Discomfort

  MAUDE report 21649271 ↗