TECNIS ODYSSEY IOL DRN00V (REF DRN00V0230)Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 05050474810822), received between Oct 30, 2023 and May 21, 2026 — classified as 15 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryMay 21, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT A PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S LEFT EYE DUE TO LENS DISPLACEMENT. THE LENS WAS REPLACED WITH A LIGHT ADJUSTABLE IOL. NO ADDITIONAL SURGICAL INTERVENTIONS, SUCH AS VITRECTOMY, SUTURING, OR INCISION ENLARGEMENT, WERE REQUIRED. IT IS UNKNOWN WHETHER THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT, AND NO PRE-EXISTING PATIENT CONDITIONS WERE REPORTED. NO PATIENT INJURY (E.G., CAPSULAR TEAR) WAS OBSERVED, AND IT IS UNKNOWN WHETHER THE PATIENT EXPERIENCED LIMITATIONS IN DAILY ACTIVITIES PRIOR TO EXPLANT. THE CURRENT PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 25246433 ↗
• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2026, A PATIENT EXPERIENCED A MYOPIC SURPRISE, BLURRED VISION, AND DISSATISFACTION FOLLOWING A PROCEDURE INVOLVING THE DEVICE. THE ORIGINAL SURGERY OCCURRED ON (B)(6) 2025; AN EXPLANT WAS PERFORMED ON (B)(6) 2026, AND THE INTRAOCULAR LENS WAS REPLACED WITH THE SAME MODEL LOWER DIOPTER LENS. THE PATIENT'S CURRENT STATUS IS UNKNOWN, AND NO PATIENT HARM WAS REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 24876914 ↗
• InjuryApr 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). POST-OPERATIVELY, VISUAL OUTCOMES DID NOT MEET STANDARD, THE PATIENT WAS UNHAPPY, AND HER DAILY ACTIVITIES WERE SIGNIFICANTLY AFFECTED. THUS, THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A NON-JOHNSON & JOHNSON SURGICAL VISION LENS, AN EEU 24.5 IOL. THERE WAS NO MEDICAL ATTENTION, NO PROCEDURAL DELAYS, NO SUTURES, AND NO VITRECTOMY DURING THE IOL EXPLANT PROCEDURE HOWEVER, THE INCISION WAS ENLARGED AND POSTOP EYE DROPS WERE PRESCRIBED. THE PRESCRIBED EYE DROPS WERE CONFIRMED TO BE PART OF STANDARD CARE. BEST CORRECTED VISUAL ACUITY (BCVA) PRE-OPERATIVE WAS 20/20 AND POST-OPERATIVE WAS 20/30. PATIENT PROGNOSIS POST LENS EXCHANGE WAS REPORTED AS FULLY RECOVERED. THE SUSPECT IOL IS NOT AVAILABLE FOR INVESTIGATION AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24860648 ↗
• InjuryApr 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL), MODEL DRN00V, WAS EXPLANTED FROM THE PATIENT¿S RIGHT EYE FOR AN UNKNOWN REASON. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH IMPLANTATION OF A REPLACEMENT LENS OF THE SAME MODEL (DRN00V, +21.0 D), WITH A 2.0-DIOPTER DIFFERENCE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 24793334 ↗
• InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL), MODEL DRN00V, WAS IMPLANTED IN THE PATIENT¿S LEFT EYE. DURING A POSTOPERATIVE EXAMINATION, POSTERIOR CAPSULAR OPACIFICATION (PCO) WAS IDENTIFIED. THE PCO WAS TREATED WITH YAG LASER CAPSULOTOMY PRIOR TO THE PATIENT¿S ENROLLMENT IN THE STUDY. THE IOL REMAINED IMPLANTED, AND NO PATIENT HARM WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Posterior Capsule Opacification

  MAUDE report 24564961 ↗
• InjuryJan 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE LEFT EYE, THE PATIENT REPORTED EXPERIENCING EXCESSIVE GLARE AND BLURRED VISION, DESPITE THE LENS BEING WELL-CENTERED AND NO OTHER ISSUES WITH THE EYE. THE ISSUE WAS FIRST NOTED DURING A POST-OPERATIVE VISIT. THE PATIENT WAS SCHEDULED TO UNDERGO AN IOL EXCHANGE PROCEDURE. THROUGH FOLLOW UP, IT WAS CONFIRMED THAT THE EXPLANT WAS SUCCESSFULLY COMPLETED. ANOTHER JOHNSON AND JOHNSON IOL WAS IMPLANTED AS REPLACEMENT; AR40E MODEL WITH A DIOPTER OF 21.5. THE EXCHANGE PROCEDURE INCLUDED A PLANNED VITRECTOMY, BUT NO SUTURES OR ADDITIONAL MEDICATIONS OUTSIDE THE STANDARD OF CARE WERE REQUIRED. THERE WAS NO PATIENT INJURY, AND VISUAL ACUITY AND SYMPTOMS IMPROVED POST-EXCHANGE. THE POST-OPERATIVE REFRACTION FOLLOWING THE EXCHANGE WAS -0.50+0.50X113. THE PRE-OPERATIVE REFRACTION WAS +2.75+0.25X005, AND THE PRE-OPERATIVE BEST SPECTACLE CORRECTED VISUAL ACUITY (BSCVA) WAS 20/30-. POST-OPERATIVE REFRACTION WITH THE ORIGINALLY IMPLANTED LENS WAS +0.50 SPHERE, AND THE POST-OPERATIVE BSCVA WAS 20/50, WITH AN INTENDED TARGET REFRACTION OF PLANO SPHERE. THE PATIENT WAS NOT OVER OR UNDER CORRECTED, AND DID NOT

  Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment

  MAUDE report 24126764 ↗
• InjuryDec 11, 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). DUE TO COMPLAINTS OF HALOS THAT AFFECTED THE PATIENT'S ABILITY TO DRIVE AT NIGHT, THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A NON-JOHNSON & JOHNSON SURGICAL VISION LENS WITH SN: (B)(6). THERE WAS NO MEDICAL INTERVENTION SUCH AS INCISION ENLARGEMENT, SUTURES, AND VITRECTOMY DURING THE LENS EXCHANGE PROCEDURE. PATIENT PROGNOSIS POST LENS EXCHANGE WAS REPORTED AS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Halo

  MAUDE report 23786148 ↗
• MalfunctionOct 31, 2025Scratched Material; Scratched Material

  IT WAS REPORTED THAT A PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) MODEL DRN00V WAS CAME OUT OF THE PRELOADED INJECTOR WITH A LARGE CENTRAL SCRATCH/GASH. THE LENS WAS FULLY INSERTED INTO THE PATIENT'S LEFT EYE BUT WAS NOT PLACED CORRECTLY. IT WAS IMMEDIATELY REMOVED AND INSERTED A NEW ONE WITH A NON-JOHNSON AND JOHNSON DEVICE OF 22.5 DIOPTER WITHOUT ANY REPORTED ISSUES FOR THE PATIENT. THERE WERE NO REPORT OF CAPSULE TEAR, UNPLANNED VITRECTOMY, INCISION ENLARGEMENT AND SUTURES. THE PATIENT WAS DOING WELL. NO MEDICATIONS OUTSIDE OF THE STANDARD CARE WERE PRESCRIBED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23441397 ↗
• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL), WAS EXPLANTED DUE TO DYSPHOTOPSIA. THE SURGEON BELIEVES THAT THE ISSUE IS THE PATIENT'S "LIDS/CORNEA" AND NOT THE LENS CAUSING THE DYSPHOTOPSIA. DURING THE LENS EXCHANGE PROCEDURE, NO SUTURES WERE USED, AND NO VITRECTOMY WAS PERFORMED. THE PATIENT OUTCOME IS UNKNOWN. THE DEVICE WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 23373839 ↗
• MalfunctionSep 3, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT AFTER THE IMPLANTATION OF ODYSSEY INTRAOCULAR LENS (IOL) INTO PATIENT'S EYE, SURGEON OBSERVED UNDER THE MICROSCOPE THAT A BIG CHUNK WAS TAKEN OUT OF THE OPTIC. THE CHUNK WAS LOCATED "PARACENTRAL" NEAR THE CENTER OF THE OPTIC AND TOWARD THE PARACENTESIS. AS A RESULT, THE SURGEON CUT THE LENS OUT AND EXPLANTED IT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A BACKUP LENS OF SAME MODEL AND DIOPTER. PHOTOS AND VIDEO OF THE DAMAGED IOL WERE PROVIDED. THERE WAS NO INJURY; HOWEVER, IT EXTENDED THE SURGERY TIME FOR 15 MINUTES. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22959285 ↗
• InjuryJul 9, 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 DYSPHOTOPSIA AND THE IOL WAS EXPLANTED. THERE WERE NO COMPLICATIONS SUCH AS CAPSULE TEAR, VITRECTOMY, INCISION ENLARGEMENT OR SUTURES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 22465505 ↗
• InjuryJun 11, 2025Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error

  THE DRN00V MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). DUE TO COMPLAINTS OF WRONG POWER AND BLURRED VISION, THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A DRT150 23.5 IOL. THERE WAS NO MEDICAL INTERVENTION AND NO SURGICAL INTERVENTION DURING THE LENS EXCHANGE PROCEDURE. PATIENT PROGNOSIS POST LENS EXCHANGE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 22185882 ↗
• InjuryMay 29, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE DUE TO UNSPECIFIED REASON. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AND REPLACED WITH ANOTHER LENS. FROM ADDITIONAL INFORMATION IT WAS LEARNT THAT THE LENS WAS EXPLANTED DUE TO DISPLACEMENT. NO OTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 22105648 ↗
• InjuryMay 21, 2025Adverse 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 PATIENT'S RIGHT EYE AS THE PATIENT HAD EXPERIENCED DYSPHOTOPSIAS. THERE WAS NO PATIENT INJURY. FROM ADDITIONAL INFORMATION IT WAS LEARNT THAT THE LENS HAD CONTRIBUTED DYSPHOTOPSIA. THERE WAS NO PATIENT ISSUES. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AND REPLACED WITH A SAME MODEL AND SAME DIOPTER LENS. THERE WAS NO USE ERROR. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 22063413 ↗
• MalfunctionMay 6, 2025Break; Device Difficult to Setup or Prepare; Scratched Material; Break; Device Difficult to Setup or Prepare; Scratched Material

  IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS INSERTED INTO THE PATIENT¿S RIGHT EYE. THE DEVICE HAD AN INJECTION ISSUE. THE IOL CAME OUT WITH SOME MILD RESISTANCE. THE IOL WAS SEVERELY DAMAGED WITH DEEP SCRATCHES ON THE OPTIC AND THE TRAILING HAPTIC OPTIC JUNCTION HAD A DEEP JAGGED DEFECT. THIS CAUSED A POSTERIOR CAPSULE RUPTURE. THE IOL WAS REMOVED AND REPLACED WITH A SULCUS IOL. THE PHYSICIAN SUSPECTS THE PRELOADED IOL HAD BEEN PREPPED TOO FAR IN ADVANCE AND THEN CAUSED THE ISSUE BUT CANNOT RULE OUT SOME ISSUE WITH THE PRELOADED INJECTOR. THE PATIENT IS EXPECTED TO DO WELL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 21973371 ↗
• 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 EXPLANTED DUE TO THE PATIENT EXPERIENCING HALOS AT NIGHT. THE PATIENT WAS NOT INJURED. THERE WERE NO COMPLICATIONS SUCH AS A CAPSULE TEAR, VITRECTOMY, INCISION ENLARGEMENT, SUTURES OR MEDICATION TO PREVENT PERMANENT IMPAIRMENT. A LIGHT ADJUSTABLE LENS (LAL) WAS IMPLANTED. THE PATIENT¿S OUTCOME WAS REPORTED AS ¿DOING FINE¿. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo

  MAUDE report 21649042 ↗
• InjuryDec 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE MODEL DRN00V 23.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OCULAR SINISTER (LEFT EYE). DURING POST-OPERATIVE EXAM SITE VISIT, PATIENT REPORTED OF BEING EXTREMELY BOTHERED BY STARBURSTS THAT HE IS UNABLE TO DRIVE AT NIGHT AND DIFFICULTY WITH VISION IN LOW LIGHT. THERE ARE NO PLANS FOR MEDICAL OR SURGICAL INTERVENTION TO ADDRESS REPORTED ISSUES. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT REMAINS IMPLANTED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT CAPTURES THE OCULAR SINISTER (LEFT EYE) IOL. A SEPARATE REPORT WILL BE FILED FOR THE PATIENT'S OCULAR DEXTER (RIGHT EYE).

  Patient problems: Blurred Vision; Flashers

  MAUDE report 18360567 ↗
• InjuryOct 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO THE PATIENT¿S CAPSULE TEAR. THE IOL WAS REPLACED WITH A SULCUS LENS. THE EXPLANTED IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 18035904 ↗