TECNIS ODYSSEY IOL DRN00V (REF DRN00V0255)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474810877), received between Jan 13, 2025 and Feb 17, 2026 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (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.

• InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S RIGHT EYE. IT WAS REPORTED THAT THERE WAS AN IOL MECHANICAL COMPLICATION DUE TO THE PATIENT WAS UNHAPPY WITH THEIR GLARE AND HALOS FROM THE ODYSSEY LENS. THE SYMPTOMS WERE DEBILITATING AS THEY COULD NOT DRIVE AT NIGHT. BEST CORRECTED VISUAL ACUITY (BSCVA) PRE-OPERATIVELY WAS REPORTED AS 20/30, POST OPERATIVELY WAS 20/35. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, SUTURES, OR MEDICATION OUTSIDE THE STANDARD OF CARE. THE PATIENT¿S OUTCOME WAS REPORTED AS ¿FULLY RECOVERED.¿

  Patient problems: Halo; Visual Disturbances

  MAUDE report 24370880 ↗
• InjuryFeb 13, 2026Adverse Event Without Identified Device or Use Problem

  THE DRN00V MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). DUE TO COMPLAINTS OF POWER MISS, THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A DRN00V 24.0 IOL. THERE WAS NO MEDICAL INTERVENTION DURING THE EXPLANT PROCEDURE HOWEVER, PATIENT OUTCOME POST PROCEDURE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 24340066 ↗
• InjuryNov 20, 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 INTO THE PATIENT¿S LEFT EYE. THE PATIENT EXPERIENCED HALOS. THE IOL WAS EXPLANTED AND REPLACED WITH AN IOL FROM A DIFFERENT COMPANY. THERE WERE NO COMPLICATIONS SUCH AS CAPSULE TEAR, VITRECTOMY OR SUTURES. NO MEDICATION OUTSIDE THE STANDARD OF CARE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Halo

  MAUDE report 23612789 ↗
• MalfunctionMay 29, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  THE DRN00V MODEL INTRAOCULAR LENS (IOL) DID NOT OPEN CORRECTLY IN THE PATIENT'S OCULAR SINISTER (LEFT EYE). THERE WAS NO USE ERROR AND NO MEDICAL INTERVENTION AND NO SURGICAL INTERVENTION DURING THE PROCEDURE HOWEVER, IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED USING ANOTHER IOL. PATIENT PROGNOSIS POST-PROCEDURE IS ALSO UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22111321 ↗
• MalfunctionJan 13, 2025Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS IMPLANTED AND SUBSEQUENTLY REMOVED DURING THE SAME SURGERY DUE TO THE LENS BEING SCRATCHED. NO PATIENT ISSUES WERE REPORTED. IT IS UNKNOWN IF ANY SURGICAL OR MEDICAL INTERVENTIONS WERE REQUIRED OR PLANNED. A BACKUP LENS WAS UTILIZED TO COMPLETE THE CASE WITHOUT CAUSING HARM TO THE PATIENT. THE PATIENT'S OUTCOME IS REPORTED AS FINE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21138130 ↗