TECNIS ODYSSEY IOL DRN00V (REF DRN00V0170)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474810709), received between Sep 7, 2024 and Jun 30, 2026 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Application Program Problem: Dose Calculation Error” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT MULTIPLE ISSUES WERE ENCOUNTERED WITH INTRAOCULAR LENSES (IOLS) DURING A SURGICAL PROCEDURE. THE FIRST LENS WAS DAMAGED DURING DELIVERY PREPARATION WHEN THE INSERTER CRUSHED THE LENS, PREVENTING ITS USE. A SECOND LENS WAS SUBSEQUENTLY IMPLANTED; HOWEVER, IT REQUIRED EXPLANTATION DUE TO A HAPTIC ADHERING TO THE CENTRAL OPTIC. A THIRD LENS, INTENDED AS A REPLACEMENT, COULD NOT BE USED BECAUSE THE INSERTER ADVANCED TO THE SIDE OF THE LENS RATHER THAN PROPERLY ENGAGING IT. NO ADDITIONAL PATIENT OUTCOMES OR ADVERSE EVENTS WERE REPORTED. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR THE SECOND LENS (DRN00V0170, SN (B)(6)). A SEPARATE REPORT WILL BE SUBMITTED FOR THE FIRST LENS (DIU300U180, SN (B)(6)).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25673802 ↗
• InjuryJun 1, 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 PATIENTS RIGHT EYE. AFTER THE IMPLANT THE PATIENT EXPERIENCED BLURRY VISION. THE IOL WAS EXPLANTED AND REPLACED WITH A NON-JOHNSON AND JOHNSON MODEL, LI61A0 BNL. THE PATIENT WAS NOT HARMED AND IS DOING WELL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 25352758 ↗
• MalfunctionApr 29, 2026Device Difficult to Setup or Prepare; Mechanical Jam

  IT WAS REPORTED THAT DURING IMPLANTATION OF A PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL), RESISTANCE WAS ENCOUNTERED AND THE LENS BECAME STUCK WITHIN THE CARTRIDGE. THE LENS WAS NOT IMPLANTED, AND A BACKUP LENS OF THE SAME MODEL AND DIOPTER WAS USED TO COMPLETE THE PROCEDURE. UNPLANNED SUTURES WERE REQUIRED; HOWEVER, IT WAS INDICATED THAT SUTURES ARE NOT PART OF THE PHYSICIAN¿S STANDARD PRACTICE, AND THE REASON FOR THEIR USE IS UNKNOWN. THE CARTRIDGE TIP CONTACTED THE PATIENT¿S RIGHT EYE. NO SURGICAL DELAY, UNPLANNED VITRECTOMY, OR INCISION ENLARGEMENT WAS REPORTED. NO PATIENT INJURY (E.G., CAPSULE TEAR) OCCURRED, AND THE DEGREE OF RESISTANCE WAS NOT SPECIFIED. TRYPAN BLUE WAS USED ON AN AS-NEEDED BASIS AND IS NOT CONSIDERED OUTSIDE THE STANDARD OF CARE. THE PATIENT FULLY RECOVERED WITH NO REPORTED IMPACT ON DAILY ACTIVITIES. DIRECTIONS FOR USE WERE FOLLOWED. PRODUCT RETURN STATUS IS UNKNOWN AND THE LENS WAS LIKELY DISCARDED POST-PROCEDURE. DEVICE PREPARATION INCLUDED FILLING THE CARTRIDGE WITH BALANCED SALT SOLUTION (BSS) VIA THE HYDRATION PORT, AND THE LENS WAS INITIALLY ADVANCED BY A SURGICAL TECHNICIAN. ADDITIONAL DETAILS, INCLUDING THE NUMBER OF TWISTS, TIMING PRIOR TO HANDPI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25029750 ↗
• InjuryNov 13, 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 LEFT EYE, THE PATIENT EXPERIENCED LACK OF CLARITY WITH VISION. THE PATIENT SYMPTOMS PERSISTED FOR FOUR WEEKS. THE ISSUE WAS IDENTIFIED DURING POST-OPERATIVE EXAMINATION. IT WAS REPORTED THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT. THE LENS WAS SUBSEQUENTLY EXPLANTED IN A SECONDARY PROCEDURE AND REPLACED WITH A NON-JOHNSON AND JOHNSON IOL (+16.00 DIOPTER). AN UNPLANNED INCISION ENLARGEMENT WAS REQUIRED. NO UNPLANNED VITRECTOMY, UNPLANNED SUTURES, MEDICAL ATTENTION, OR MEDICATION OUTSIDE OF THE STANDARD OF CARE WAS REQUIRED. THERE WAS NO PATIENT INJURY AND NO DELAY IN THE PROCEDURE. THE PATIENT WAS ABLE TO PERFORM DAILY ACTIVITIES AS PRIOR TO THE SURGERY. THE PRE-OPERATIVE REFRACTION WAS RECORDED AS -1.50-0.75X 060, WITH A PRE-OPERATIVE BEST SPECTACLE CORRECTED VISUAL ACUITY (BSCVA) OF 20/50-2, AND THE INTENDED TARGET REFRACTION WAS EMMETROPIA. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF TWO OR MORE LINES OF BSCVA BUT WAS NEITHER OVER-CORRECTED NOR UNDER-CORRECTED. POST OPERATIVE REFRACTION AND BSCVA ARE UNKNOWN. THERE WERE NO PRE-EXISTING CONDITIONS AFFECTING THE LENS CA

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 23550734 ↗
• InjurySep 7, 2024Application Program Problem: Dose Calculation Error; Use of Device Problem; Application Program Problem: Dose Calculation Error; Use of Device Problem

  IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A FEMALE¿S LEFT EYE (OS=OCULUS SINISTER ). THE REASON IS THAT THE PATIENT HAD A SYMFONY IN THE FIRST EYE (RIGHT EYE) AND WANTED MORE NEAR VISION. THEREFORE, THE DOCTOR IMPLANTED THE ODYSSEY IN THE LEFT EYE (SECOND EYE). THE PATIENT¿S LEFT EYE ENDED UP ½ DIOPTER HYPEROPIC AND DIDN¿T GET ENOUGH NEAR AS A RESULT. CONSEQUENTLY, THE DOCTOR DECIDED TO ADJUST FOR THE OUTCOME AND SWITCH TO ANOTHER JOHNSON AND JOHNSON LENS MODEL ZCB00 21.5 DIOPTER. THE AIM IS TO END UP -3.0 SO THE PATIENT WILL HAVE GOOD NEAR VISION IN THE THAT EYE. WHEN THE EVENT WAS REPORTED TO JNJ THE PATIENT WAS J3 WITH SOME EDEMA. (J3=20/40 ON THE JAEGER VISUAL ACUITY EYE CHART). THE DOCTOR THINKS IF HE HAD HIT HIS TARGET, THE PATIENT WOULD HAVE LIKELY BEEN FINE. THE PATIENT IS DOING WELL AND SEEING J1 (J1=20/25) FOR NEAR WITH HER JNJ REPLACEMENT LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Corneal Edema; Visual Impairment

  MAUDE report 20164688 ↗