TECNIS ODYSSEY IOL DRN00V (REF DRN00V0240)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05050474810846), received between Feb 18, 2025 and Apr 23, 2026 — classified as 5 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED TORIC INTRAOCULAR LENS (IOL) IS PLANNED FOR AN IOL EXCHANGE TO A MONOFOCAL LENS AS THE PATIENT IS BOTHERED BY HALO AND GLARE AT NIGHT. THE PATIENT HAS 20/20 VISION AND J1 NEAR ACUITY IN BOTH EYES. THE PATIENT CANNOT PERFORM PRIOR TO SURGERY LIKE DRIVING AT NIGHT HAS AFFECTED THE DAILY ACTIVITY. PREOPERATIVE BEST CORRECTED VISUAL ACUITY (BSCVA) WAS 20/30 AND 20/20 , POSTOPERATIVELY. NO UNPLANNED INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES REQUIRED. THE PATIENT IS TEMPORARILY IMPAIRED. THE LENS IS NOT AVAILABLE FOR RETURN AS IT REMAINS IMPLANTED. ADDITIONAL INFORMATION RECEIVED ON MARCH 31, 2026, CONFIRMED THAT EXPLANT WAS PERFORMED FROM THE RIGHT EYE (OD). THE REPLACEMENT LENS IS A NON¿JOHNSON AND JOHNSON LENS. THE PATIENT IS UNABLE TO EXERCISE AND IS UNSURE IF THIS IS DUE TO THE IOL OR ANOTHER CAUSE. THE PATIENT IS NEITHER OVERCORRECTED NOR UNDER CORRECTED AND DID NOT LOSE TWO OR MORE LINES OF BSCVA (BEST SPECTACLE CORRECTED VISUAL ACUITY). THE PREOPERATIVE REFRACTION WAS +1.00 +0.50 × 144 WITH A BSCVA OF 20/25. THE POSTOPERATIVE REFRACTION WAS PLANO SPHERE WITH A BSCVA OF 20/20. THE INTENDED TARGET REFRACTION WAS PLANO, AND THE POSTOP REFRACTION

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 24968731 ↗
• InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SINGLE-PIECE PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) IN THE PATIENT¿S RIGHT EYE DEVELOPED POSTERIOR CAPSULE OPACIFICATION (PCO). THE EVENT WAS IDENTIFIED DURING A POSTOPERATIVE EXAMINATION. THE PCO WAS TREATED WITH A YAG LASER CAPSULOTOMY PRIOR TO THE PATIENT¿S ENROLLMENT IN THE STUDY. THE IOL REMAINS IMPLANTED, AND NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION INDICATED THAT THE PREOPERATIVE REFRACTION WAS +2.25 -0.50 × 090, AND THE POSTOPERATIVE REFRACTION WAS +0.25 -0.25 × 180. BOTH PREOPERATIVE AND POSTOPERATIVE BSCVA WERE 20/20. IT WAS UNKNOWN WHETHER THE PATIENT LOST ANY LINES OF VISUAL ACUITY. IT WAS ALSO UNKNOWN WHETHER THE PATIENT WAS OVER- OR UNDER-CORRECTED, AND THE INTENDED REFRACTIVE TARGET WAS NOT PROVIDED. NO PRE-EXISTING CONDITIONS AFFECTING IOL POWER CALCULATION WERE REPORTED. THE PATIENT¿S DAILY ACTIVITIES WERE NOT AFFECTED. NO UNPLANNED SURGICAL INTERVENTIONS SUCH AS INCISION ENLARGEMENT, SUTURES, OR VITRECTOMY WERE REQUIRED. NO MEDICATIONS OUTSIDE THE STANDARD OF CARE WERE PRESCRIBED. THE FINAL PATIENT OUTCOME WAS NOT REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Posterior Capsule Opacification

  MAUDE report 24564897 ↗
• MalfunctionJan 30, 2026Break; Device Difficult to Setup or Prepare; Scratched Material

  IT WAS REPORTED THAT THE PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) HAD MULTIPLE INDENTATIONS, MARKS, AND SCRATCHES, WHICH WERE IDENTIFIED DURING IMPLANTATION. IT WAS ALSO NOTED THAT AN ENLARGED WOUND HAD BEEN CREATED WITH A 2.4 MM KERATOME PRIOR TO INJECTION. THE IMPLANTED LENS WAS NOT REMOVED. THROUGH FOLLOW-UP, IT WAS CONFIRMED THAT DESPITE THE OBSERVED DAMAGE INCLUDING A CRACK MEASURING APPROXIMATELY 2.5 MM × 1 MM LOCATED PARACENTRALLY, THE LENS REMAINED IMPLANTED. THE INJECTOR WAS NOTED TO BE SLIGHTLY MORE DIFFICULT TO TURN; HOWEVER, THIS DID NOT RAISE CONCERNS REGARDING THE INTEGRITY OF THE LENS. NO PATIENT INJURY, CAPSULE TEAR, OR UNPLANNED MEDICAL OR SURGICAL INTERVENTIONS, SUCH AS VITRECTOMY, INCISION ENLARGEMENT, OR SUTURING, WERE REQUIRED. THE IOL WAS LOADED WITH BALANCED SALT SOLUTION (BSS). THE LENS IS NOT AVAILABLE FOR RETURN, AS IT REMAINS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24219545 ↗
• MalfunctionNov 26, 2025Scratched Material; Scratched Material

  IT WAS REPORTED THAT A PRELOADED MULTIFOCAL ONE-PIECE INTRAOCULAR LENS (IOL) WAS FULLY INSERTED INTO THE LEFT EYE (OS) BUT WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE AFTER A SCRATCH CAUSED BY THE TRAILING HAPTIC NOTED. NO ADDITIONAL SURGICAL MANEUVERS WERE REQUIRED TO DELIVER OR POSITION THE ORIGINAL LENS. THE REPLACEMENT WAS ANOTHER LENS OF THE SAME MODEL AND DIOPTER. THE PROCEDURE WAS COMPLETED WITHOUT DELAY AND REQUIRED NO FURTHER SURGICAL INTERVENTIONS (E.G., VITRECTOMY, SUTURES, OR INCISION ENLARGEMENT), AND NO MEDICATIONS BEYOND THE STANDARD OF CARE WERE NECESSARY. THE PATIENT IS REPORTED TO BE IN GOOD CONDITION POSTOPERATIVELY. IT WAS CONFIRMED THAT THE LENS WAS NOT KEPT FOLDED FOR MORE THAN 10 MINUTES AND THAT THE SCRATCH WAS NOT DUE TO USER ERROR. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23661587 ↗
• InjuryNov 14, 2025Device Difficult to Setup or Prepare; Use of Device Problem; Device Difficult to Setup or Prepare; Use of Device Problem

  IT WAS REPORTED BY THE CUSTOMER THAT THE PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL), MODEL DRN00V, BECAME LODGED IN THE INJECTOR DURING IMPLANTATION AND TOOK FORCE TO MAKE IT MOVE. THE LENS DID NOT FRACTURE AND WAS SUCCESSFULLY IMPLANTED IN THE PATIENT'S LEFT EYE. INTRAOPERATIVELY, THE PATIENT EXPERIENCED COMPLICATIONS, INCLUDING POSTERIOR CAPSULE RUPTURE AND INFERIOR IRIS ROOT AVULSION. NO FURTHER INFORMATION WAS PROVIDED. THIS IOL WAS A REPLACEMENT FOR A PRIOR CASE. THE EARLIER CASE DID NOT MEET REPORTABILITY CRITERIA AND REMAINS NON REPORTABLE BASED ON THE INFORMATION AVAILABLE.

  Patient problems: Capsular Bag Tear; Eye Injury

  MAUDE report 23559871 ↗
• MalfunctionJun 16, 2025Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) CAME OUT OF THE CARTRIDGE SCRATCHED. THE LENS WAS CUT OUT REMOVED AND REPLACED IN THE SAME PROCEDURE. NO PATIENT ADVERSE EVENT WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22216170 ↗
• InjuryMay 20, 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). IN A SECONDARY SURGICAL PROCEDURE, THE IOL WAS EXPLANTED DUE TO UNKNOWN REASONS AND REPLACED WITH A NON-JOHNSON & JOHNSON IOL, CCWTT0 23.5 LENS. PATIENT PROGNOSIS POST LENS EXCHANGE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 22057061 ↗
• MalfunctionMar 6, 2025Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE PRELOADED LENS HAD A DAMAGE MARK. DURING THE SURGERY, A LENS WAS INJECTED INTO THE PATIENT'S EYE, BUT IT WAS LATER DISCOVERED TO HAVE A DAMAGED MARK. THE LENS WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE WITH THE SAME MODEL AND A DIFFERENT LENS. ADDITIONAL INFORMATION STATES THAT THE DOCTOR IMPLANTED THE INITIAL LENS NORMALLY WITHOUT ANY ISSUES. ONCE THE LENS WAS IMPLANTED, A DEFECT IN THE CENTER OF THE LENS WAS NOTICED. NO INJURY OR INTERVENTION WAS REQUIRED, AND THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21541620 ↗
• InjuryFeb 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT HYPERMETROPIA LASIK SURGERY BEFORE IMPLANTATION OF THE PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL). ACCOUNT INDICATED THAT THE LENS WAS IMPLANTED, BUT AFTER THE PROCEDURE, IT WAS NOTED THAT THE REFRACTIVE VALUE WAS MISALIGNED. AS A RESULT, THE IOL WAS EXPLANTED AND REPLACED WITH A DIFFERENT LENS OF A DIFFERENT DIOPTER. THROUGH FOLLOW-UP, WE LEARNED THAT THE AFFECTED EYE WAS THE RIGHT EYE. THE PATIENT DID NOT EXPERIENCE ANY INJURIES, SURGICAL COMPLICATIONS, OR HEALTH ISSUES, AND WAS NOT HOSPITALIZED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21406029 ↗