TECNIS ODYSSEY IOL DRN00V (REF DRN00V0185)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 05050474810730), received between Sep 12, 2024 and Sep 10, 2026 — classified as 7 injuries, 6 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 18, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 2026Adverse 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 right eye. The patient experienced symptoms however, the details were not provided. The IOL was explanted and replaced with a non-Johnson and Johnson lens model LAL +19.5 diopter. The patient¿s pre-operative best corrected visual acuity (BSCVA) was reported as 20/40, post-operative 20/20. Reportedly, the directions for use were followed. There were no complications such as a vitrectomy, incision enlargement, sutures or delay in the procedure. There was no medication outside the standard of care. The patient has fully recovered. No further information was provided.

  Patient problems: Eye Injury

  MAUDE report 50718084 ↗
• MalfunctionJul 16, 2026Scratched Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25843260 ↗
• MalfunctionJun 16, 2026Break; Ejection Problem

  IT WAS REPORTED THAT DURING LEFT-EYE CATARACT SURGERY, THE SURGEON STATED THAT THE PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL), MODEL DRN00V, DEPLOYED PREMATURELY, RESULTING IN PARTIAL PLACEMENT IN THE PATIENT¿S EYE. THE LENS WAS REMOVED. THE SURGEON INDICATED THAT THE LENS WAS FAULTY AND WOULD BE RETURNED TO THE COMPANY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25527517 ↗
• 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 +16.5 DIOPTER. THE PROCEDURE WAS COMPLETED. 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 24793422 ↗
• InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT'S OPERATIVE EYE DUE TO A HYPEROPIC OUTCOME AND AS THE PATIENT WAS DISSATISFIED WITH THE INITIAL RESULT. THE LENS WAS REPLACED WITH ANOTHER IOL OF THE SAME MODEL BUT HIGHER DIOPTER (19.5 D). THE PATIENT OUTCOME WAS NOT PROVIDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 24527363 ↗
• MalfunctionFeb 13, 2026Break

  IT WAS REPORTED THAT DURING AN IMPLANTATION OF A SINGLE PIECE PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL), THE DOCTOR NOTICED THAT IT WAS CRACKED. THE EVENT WAS OBSERVED DURING THE DELIVERY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24335244 ↗
• MalfunctionNov 10, 2025Break; Break

  IT WAS REPORTED THAT AFTER THE PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE EYE, IT WAS NOTICED THAT IT HAD A PIECE MISSING. THE LENS WAS CUT OUT AND REPLACED WITH NO HARM TO THE PATIENT. THE PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23513295 ↗
• MalfunctionSep 2, 2025Break; Crack; Break; Crack

  THE INJECTOR OF THE PRE-LOADED DRN00V MODEL INTRAOCULAR LENS (IOL) WAS BENT. IT WAS NOTED PRIOR TO THE IOL BEING INSERTED IN THE PATIENT'S EYE. WHILE THE IOL ITSELF REMAINED INTACT, THERE WAS A POTENTIAL RISK OF DAMAGE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22948890 ↗
• InjuryJul 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PRE-LOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED AS THE PATIENT EXPERIENCED CLOUDY PERIPHERAL VISION IN THE RIGHT EYE. IT WAS REPLACED WITH LENS FROM ANOTHER MANUFACTURER IN A SECONDARY PROCEDURE. INCISION ENLARGEMENT, VITRECTOMY AND SUTURES WERE NOT REQUIRED. DIRECTIONS FOR USE WERE FOLLOWED. PATIENT CAN PERFORM DAILY ACTIVITIES. PATIENTS PRE-OP BEST CORRECTED VISUAL ACUITY (BSCVA) WAS 20/20 AND POST OP BSCVA WAS 20/20. POST PROCEDURE, PATIENT WAS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 22552184 ↗
• MalfunctionJun 4, 2025Scratched Material; Scratched Material

  IT WAS REPORTED BY THE CUSTOMER THAT THERE WAS A MALFUNCTION WITH A PRELOADED INSERTER, RESULTING IN THE LENS BEING SCRATCHED. THERE WAS NO PATIENT HARM, AS THE INTRAOCULAR LENSES (IOLS) HAD TO BE CUT AND REMOVED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22145976 ↗
• InjuryMay 30, 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 DUE TO DECREASED VISION. THE LENS WAS EXPLANTED AND REPLACED WITH A NON JNJ LENS IN A SECONDARY PROCEDURE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 22118063 ↗
• InjurySep 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENSES (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE DUE TO HALOS AND GLARES. THE PATIENT WAS UNABLE TO DRIVE AT NIGHT. THE LENS WAS EXPLANTED AND REPLACED WITH A NON JNJ LENS IN A SECONDARY PROCEDURE. NO OTHER INFORMATION IS AVAILABLE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 20315498 ↗
• InjurySep 12, 2024Adverse 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 FROM THE PATIENT'S LEFT EYE. THE REASON FOR THE EXPLANT IS DUE TO HALOS AND GLARE AND THE PATIENT WAS UNABLE TO DRIVE AT NIGHT. THE REPLACEMENT LENS IS A NON JNJ MODEL CLAREON CCWET0 +18.5 DIOPTER ALCON LENS. THERE WAS NO PATIENT INJURY, NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES. NO FURTHER INFORMATION WAS PROVIDED. NOTE. THE PATIENT'S RIGHT EYE SERIAL# (B)(6) IS BEING SUBMITTED IN A SEPARATE REPORT.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 20209073 ↗