TECNIS ODYSSEY IOL DRN00V (REF DRN00V0235)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 05050474810839), received between Nov 9, 2023 and Jun 12, 2026 — classified as 9 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2026Break

  IT WAS REPORTED THAT A PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) WAS OPENED ON THE SURGICAL FIELD AND OBSERVED TO HAVE A CRACK IN THE OPTIC AND WAS THEREFORE NOT USED. THE LENS WAS NOT IMPLANTED. THE HAPTICS WERE INTACT AND THERE WAS NO DAMAGE SEEN ON THE CARTRIDGE. THE TECHNICIAN DID NOT PREPARE THE LENS IN ERROR. A BACK-UP LENS OF THE SAME DIOPTER WAS SUCCESSFULLY INSERTED WITH NO ISSUES AND NO INTERVENTIONS OR PROCEDURES IMPLEMENTED. THE OUTCOME WAS FAVORABLE AND THERE WAS NO INJURY TO THE PATIENT. THE DEVICE WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25493191 ↗
• InjuryJun 8, 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 EYE. THE IOL WAS LATER REMOVED DUE TO A POWER MISS. THE REPLACEMENT LENS IS THE SAME MODEL BUT DIFFERENT DIOPTER, DRN00V 24.0 DIOPTER. THERE WAS NO VITRECTOMY OR SUTURES NEEDED. REPORTEDLY, THERE WAS NOTHING WRONG WITH THE LENS. THE PATIENT IS DOING WELL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 25429310 ↗
• InjuryApr 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SINGLE-PIECE, PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S RIGHT EYE. THE LENS WAS REMOVED DURING A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH ANOTHER IOL OF THE SAME MODEL WITH A +22.0 DIOPTER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE REASON FOR THE IOL EXCHANGE WAS NOT REPORTED. IT WAS NOTED THAT DUOVISC WAS USED DURING THE PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 24793450 ↗
• MalfunctionApr 5, 2026Ejection Problem

  WHILE INSERTING THE DRN00V MODEL INTRAOCULAR LENS (IOL) IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE), THE INJECTOR DID NOT RELEASE, THE IOL DID NOT FULLY INSERT, AND THE TRAILING HAPTIC DID NOT COMPLETELY EMERGE FROM THE INSERTER. THE LENS WAS DELIVERED UPSIDE DOWN AND REQUIRED MANUAL MANIPULATION TO FLIP THE IOL. THE WOUND WAS NOT ENLARGED, AND NO VITRECTOMY WAS PERFORMED. ON THE SAME DAY POST-OPERATION, VISUAL ACUITY WAS MEASURED AT 20/40 WITH DILATION AND MINIMAL STRIA. BY ON (B)(6) 2026, THREE DAYS AFTER THE OPERATION, VISUAL ACUITY HAD IMPROVED TO 20/20-1 WITH J3 READING ABILITY. A FOLLOW-UP APPOINTMENT WAS SCHEDULED FOR ON (B)(6) 2026. THE SUSPECT IOL IS NOT AVAILABLE FOR INVESTIGATION AS IT REMAINS IMPLANTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24787147 ↗
• InjuryDec 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE, THE PATIENT EXPERIENCED BLURRY VISION AT DISTANCE AND NEAR. THE ISSUE WAS IDENTIFIED DURING THE POST-OPERATIVE EXAMINATION. THE PRE-OPERATIVE (PRE-OP) BEST SPECTACLE CORRECTED VISUAL ACUITY (BSCVA) WAS 20/25-2. THE LENS WAS SUBSEQUENTLY EXPLANTED IN A SECONDARY SURGERY AND REPLACED WITH A NON-JOHNSON AND JOHNSON IOL. NO UNPLANNED INCISION ENLARGEMENT, SUTURES, OR VITRECTOMY WERE REQUIRED. THERE WAS NO DELAY IN PROCEDURE AND DIRECTIONS FOR USE WERE FOLLOWED. THE PATIENT DID NOT NEED ADDITIONAL MEDICAL ATTENTION OR MEDICATION OUTSIDE THE STANDARD OF CARE. THE POST-OP REFRACTION AFTER THE LENS EXCHANGE WAS 20/30-2. THE PATIENT IS GOOD AND HAS FULLY RECOVERED. PER THE ACCOUNT, THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 23723890 ↗
• MalfunctionDec 3, 2025Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) SEEMED TO HAVE SCUFF MARKS ON IT. THE ISSUE WAS NOTICED UPON INSERTION INTO THE EYE. A BACKUP LENS WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO COMPLICATIONS SUCH AS A CAPSULE TEAR, VITRECTOMY, INCISION ENLARGEMENT, SUTURES OR MEDICATION OUTSIDE THE STANDARD OF CARE. THE PATIENT¿S OUTCOME WAS REPORTED AS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE REGARDING THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23707300 ↗
• InjuryAug 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A TECNIS ODYSSEY INTRAOCULAR LENS (IOL) ON (B)(6) 2024, EXPERIENCED BLURRY FAR- AND MID-RANGE VISION AND NOTICED A SMUDGE ON THE LENS. THESE ISSUES WERE IDENTIFIED DURING A POST-OPERATIVE EXAMINATION, LEADING TO THE EXPLANTATION OF THE LENS DURING A SECONDARY SURGERY ON (B)(6) 2025. IT WAS DOCUMENTED THAT THE INSTRUCTIONS FOR USE WERE FOLLOWED, AND NO UNPLANNED SURGICAL COMPLICATIONS SUCH AS INCISION ENLARGEMENT, SUTURES, OR VITRECTOMY OCCURRED DURING THE PROCEDURES. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 22768176 ↗
• InjuryAug 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A TECNIS ODYSSEY SIMPLICITY INTRAOCULAR LENS (IOL) ON (B)(6) 2025 EXPERIENCED DIFFICULTY WITH DEPTH PERCEPTION AND CLOUDINESS AFTER IMPLANTATION. THE DIRECTION FOR USE WERE FOLLOWED. THE LENS WAS EXPLANTED DURING SECONDARY SURGERY ON (B)(6) 2025. THERE WERE NO UNPLANNED SURGICAL COMPLICATIONS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 22768174 ↗
• InjuryMay 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS LEAKING VITREOUS FLUID FROM A SMALL OPENING IN THE POSTERIOR CAPSULE FOLLOWING THE IMPLANTATION OF THE DRN00V MODEL INTRAOCULAR LENS (IOL). THERE WAS NO COMPLAINT AGAINST THE LENS. THE IOL WAS REMOVED AND THE SAME PROCEDURE WAS COMPLETED SUCCESSFULLY USING A NON-JOHNSON & JOHNSON IOL, LI61A0 +21.5 DIOPTER LENS THAT WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). INCISION ENLARGEMENT WAS PERFORMED DURING VISCOELASTIC REMOVAL AFTER LENS PLACEMENT AND UNPLANNED SUTURES WERE REQUIRED. HOWEVER, THE SUTURES WERE USED AS A PROPHYLACTIC MEASURE. THERE WAS NO SERIOUS PATIENT INJURY AND NOR VITRECTOMY. PATIENT PROGNOSIS POST-PROCEDURE WAS REPORTED AS GOOD. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Corneal Perforation; Vitreous Hemorrhage

  MAUDE report 21999742 ↗
• InjuryMar 31, 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 EYE AS PATIENT COMPLAINED OF BLURRY AND HAZZY VISION WITH GHOSTING AND CRESCENT SHAPED SHADOW. THE LENS WAS EXPLANTED AND REPLACED WITH LENS FROM ANOTHER MANUFACTURER IN A SECONDARY PROCEDURE. THERE WAS NO PATIENT INJURY. THERE WAS NO MEDICAL/SURGICAL INTERVENTION REQUIRED. THE PATIENT IS DOING GOOD. FROM ADDITIONAL INFORMATION IT WAS LEARNT THAT THE LENS HAD CONTRIBUTED FOR BLURRY AND HAZY VISION WITH GHOSTING AND CRESCENT SHAPED SHADOW. THERE WAS NO USE ERROR. THE REPLACED LENS HAD CORRECTED THE VISUAL ISSUES AND THE PATIENT FEELS BETTER WITH THE REPLACED LENS. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Vitreous Floaters

  MAUDE report 21735592 ↗
• MalfunctionMar 28, 2025Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE HAPTICS WERE TORQUED AND THE OPTIC APPEARED DEFECTIVE.THE ISSUE WAS OBSERVED AFTER INSERTION. THE DEVICE WAS EXPLANTED AND CUT OUT, AND THE SURGEON USED A BACKUP LENS FOR REPLACEMENT. THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21727088 ↗
• MalfunctionMar 19, 2025Scratched Material; Scratched Material

  IT WAS REPORTED BY THE SURGEON THAT THE INSERTER OF THE PRELOADED INTRAOCULAR LENS (IOL) DID NOT FIT THROUGH THE 2.4 INCISION IN THE RIGHT EYE OF THE PATIENT. THE INCISION WAS ENLARGED AND LENS WAS IMPLANTED, BUT THE LENS WAS SCRATCHED. SURGEON REPORTED THAT THE PATIENT IS FINE AND LENS REMAINS IMPLANTED IN THE PATIENT EYE AND NO EXPLANT WAS PERFORMED. THE ISSUE WAS OBSERVED DURING AND AFTER INSERTION OF THE LENS. THERE WERE NO MEDICAL/SURGICAL INTERVENTION REQUIRED. THE PATIENT IS DOING FINE. NO OTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 21647771 ↗
• InjuryJan 24, 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) IN THE RIGHT EYE WILL BE EXCHANGED ON (B)(6) 2025 FOR A "STAND/ASPIRE-TORIC". THE TARGET REFRACTION FOR THE INITIALLY IMPLANTED LENS WAS PLANO. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 21235669 ↗
• MalfunctionOct 28, 2024Break; Break

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) HAD A MINOR DAMAGE TO THE EDGE OF THE OPTIC, LIKELY DUE TO TECH ERROR WHEN LOADING. THE LENS WAS NOT EXPLANTED. FROM ADDITIONAL INFORMATION IT WAS LEARNT THAT THERE WAS NO DAMAGE NOTICED UNTIL THE LENS WAS IN THE EYE SO IT'S UNCLEAR IF IT WAS DAMAGED IN THE INSERTION OR IF IT WAS ALREADY LIKE THAT. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20551410 ↗
• MalfunctionJun 18, 2024Break; Break

  IT IS REPORTED THAT THE INTRAOCULAR LENS WAS CRACKED. THE SURGEON DEPLOYED THE ODYSSEY IOL AND AS HAPTICS WERE UNFOLDING, IT WAS NOTICED THAT THERE WAS A CRACK IN THE LENS. THE SURGEON CUT OUT THE DEFECTIVE ODYSSEY LENS, REMOVED IT, AND IMPLANTED A BACK-UP ODYSSEY DRN00V 23.5D LENS. THE DEFECTIVE LENS IS AVAILABLE FOR RETURN. NO INJURY OR MEDICAL INTERVENTION IS REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19564078 ↗
• InjuryNov 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE TECNIS ODYSSEY SIMPLICITY INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE LEFT EYE DUE TO PATIENT UNABLE TO READ SMALL PRINT. THERE WERE NO OTHER MEDICAL/SURGICAL INTERVENTIONS REQUIRED. THE LENS WAS REPLACED WITH A ZLB00 23.5 D LENS IN SECONDARY PROCEDURE. PATIENT IS DOING WELL. ADDITIONAL INFORMATION RECEIVED STATED THAT THERE WAS NO PATIENT INJURY. PATIENT ALSO HAD HALOS AT NIGHT AND HEATWAVE IN VISION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Halo

  MAUDE report 18103996 ↗