TECNIS ODYSSEY IOL DRN00V (REF DRN00V0165)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 05050474810693), received between Dec 22, 2023 and Sep 18, 2026 — classified as 8 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50830440 ↗
• MalfunctionApr 23, 2026Break; Mechanical Jam

  IT WAS REPORTED THAT A SINGLE PIECE PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) WOULD NOT ADVANCE CORRECTLY WHEN USING AND THE FRONT HAPTIC WAS QUESTIONABLE. THE PATIENT CONTACT WAS UNKNOWN AS OF YET. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24974878 ↗
• InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem

  THE DRN00V MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE). POST-OPERATIVELY PATIENT REPORTS COMPLAINTS CONSISTENT OF BLURRY NEAR VISION, GLARE HALOS, AND STARBURSTS THAT HAVE NOT IMPROVED OVER TIME OR WITH DRY EYE THERAPY. THERE IS NO PATIENT HARM. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT REMAINS IMPLANTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Dry Eye(s); Flashers; Halo; Visual Disturbances

  MAUDE report 24646384 ↗
• MalfunctionFeb 23, 2026Scratched Material

  IT WAS REPORTED THAT DURING INSERTION, THE PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL), MODEL DRN00V, BECAME SCRATCHED. PATIENT CONTACT OCCURRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24417331 ↗
• MalfunctionDec 26, 2025Break; Break

  IT WAS REPORTED THAT THERE WAS A LENS MALFUNCTION DURING A PROCEDURE INVOLVING A PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL). IT IS UNKNOWN WHETHER THE LENS WAS PARTIALLY INSERTED OR FULLY INSERTED, AND THE LENS WAS SUBSEQUENTLY CUT OUT. THERE WAS NO TIP CARTRIDGE DAMAGE OR HAPTIC/OPTIC DAMAGE ISSUE REPORTED. THERE WAS NO REPORT OF USER APPLYING FORCE TO DELIVER THE LENS. THERE WAS NO UNPLANNED MEDICAL OR SURGICAL INTERVENTIONS SUCH AS VITRECTOMY, INCISION ENLARGEMENT OR SUTURES REQUIRED. THERE WAS NO PATIENT INJURY OR ADVERSE EVENTS REPORTED IN CONNECTION WITH THIS INCIDENT. NO REPORT WHETHER THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT. THE PROCEDURE WAS COMPLETED USING A BACKUP LENS OF THE SAME MODEL AND DIOPTER. THE PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23898912 ↗
• InjuryAug 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TECNIS ODYSSEY SIMPLICITY 16.5 D INTRAOCULAR LENS (IOL) ON (B)(6) 2025 IN THE RIGHT EYE (OD) INITIALLY REPORTED SYMPTOMS OF BLURRED AND HAZY VISION, FOLLOWED BY DIFFICULTY READING AND MILD BLURRED VISION AT A DISTANCE. ON (B)(6) 2025, THE LENS WAS EXPLANTED DURING A SECONDARY SURGERY AND REPLACED WITH THE SAME MODEL INTRAOCULAR LENS OF 17 D. THE PROCEDURE DID NOT REQUIRE UNPLANNED INCISION ENLARGEMENT, SUTURES, OR VITRECTOMY, AND THERE WAS NO PROCEDURAL DELAY. THE PATIENT¿S PRE-OPERATIVE BEST CORRECTED VISUAL ACUITY WAS 20/25-2, AND POST-OPERATIVE VISUAL ACUITY IMPROVED TO 20/20. THE PATIENT WAS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 22913459 ↗
• InjuryJul 15, 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 SINISTER (LEFT EYE). POST-OPERATIVELY, THE PATIENT HAD AN HYPEROPIC OUTCOME, THUS THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A DRT150 17.0 DIOPTER IOL. PATIENT PROGNOSIS POST LENS EXCHANGE IS UNKNOWN. PATIENT INFORMATION CANNOT BE PROVIDED DUE TO PERSONAL DATA PRIVACY LEGISLATION/POLICY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 22516382 ↗
• InjuryMay 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER IMPLANTATION OF ODYSSEY INTRAOCULAR LENS (IOL), PATIENT COMPLAINED OF NO VISION IMPROVEMENT. PATIENT STRUGGLED TO READ STREET SIGNS AND TO READ ON TABLET. IOL WAS EXPLANTED IN SECONDARY PROCEDURE AND ANOTHER LENS OF SAME MODEL WAS IMPLANTED. PRE OPERATIVE BEST SPECTACLE CORRECTED VISUAL ACUITY (BSCVA) WAS 20/20-1 AND POST OPERATIVE BSCVA WAS 20/20. NO UNPLANNED INCISION ENLARGEMENT AND UNPLANNED SUTURES REQUIRED. NO UNPLANNED VITRECTOMY WAS REQUIRED. THERE WAS NO DELAY IN PROCEDURE. NO MEDICATIONS WERE PRESCRIBED. PATIENT WAS FULLY RECOVERED. NO FURTHER INFROMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 22015038 ↗
• InjuryMay 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED LENS WAS EXPLANTED BECAUSE THE PATIENT COMPLAINED OF NO VISION IMPROVEMENT, STRUGGLES TO READ STREET SIGNS AND TABLET. THE LENS WAS REMOVED AND REPLACED DURING A SECONDARY SURGICAL PROCEDURE WITH ANOTHER SAME MODEL J&J LENS. THE PATIENT'S VISUAL ACUITY PRE OPERATIVE WAS 20/30-1 AND POST OPERATIVE NOW 20/20, AND THEY HAVE FULLY RECOVERED. NO FURTHER INJURIES OR INTERVENTIONS ARE REQUIRED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 22007309 ↗
• InjuryDec 26, 2024Adverse 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 AND LEFT EYE THE PATIENT EXPERIENCED SEVERAL POST-OPERATIVE COMPLICATIONS. FOLLOWING THE SURGERY, THE PATIENT EXPERIENCED NEW SYMPTOMS IN BOTH EYES, INCLUDING VISUAL HALLUCINATIONS SUCH AS SEEING GEOMETRIC SHAPES, TREES, HILLS, FACES, AND RED WRITING ON WALLS, WHICH THE SURGEON NOTED SOUNDS LIKE CHARLES BONNET SYNDROME. TO ALLEVIATE DISCOMFORT, THE PATIENT HAS BEEN WEARING SUNGLASSES FULL-TIME SINCE SURGERY. THE PATIENT SPEND SIX DAYS AT THE EMERGENCY ROOM (ER) DUE TO EMOTIONAL DISTRESS AND VISUAL DISTURBANCES (SELF-CHECKED IN). A MAGNETIC RESONANCE IMAGING (MRI) WAS CONDUCTED AND SHOWED NO ABNORMALITIES (WITHIN NORMAL LIMITS). PSYCHIATRIC CONDITIONS, HALLUCINATIONS, AND MENTAL ILLNESS WERE ALL RULED OUT. THE PATIENT HAS BEEN ADVISED TO FOLLOW UP WITH NEURO-OPHTHALMOLOGY AND THERE IS A PLAN FOR AN INTRAOCULAR LENS EXCHANGE FROM A MULTIFOCAL TO STANDARD LENS. ADDITIONALLY, THE PATIENT HAS DEVELOPED POSTERIOR VITREOUS DETACHMENT IN BOTH EYES, A NEW CONDITION SINCE THE SURGERY, AND EXPERIENCES MONOCULAR DIPLOPIA IN BOTH EYES, WHICH WAS CONFIRMED ON (B)(6) 2024. CURRENTLY, TH

  Patient problems: Distress; Visual Disturbances; Visual Impairment; Vitreous Detachment

  MAUDE report 21021302 ↗
• InjuryDec 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DIFFICULTY IN READING AND DAILY ACTIVITY WERE SIGNIFICANTLY AFFECTED. THE LENS REMAINS IMPLANTED AND THERE IS NO PLAN TO EXPLANT. THE SURGEON PLANS TO SEE THE PATIENT AFTER 3 MONTHS. THERE WAS NO INJURY, AND SURGICAL AND MEDICAL INTERVENTIONS WERE REQUIRED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 18384001 ↗