TECNIS ODYSSEY IOL DRN00V (REF DRN00V0190)Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 05050474810747), received between Jul 2, 2024 and Sep 18, 2026 — classified as 7 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Scratched Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50827429 ↗
• InjuryMay 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE RIGHT EYE. THE PATIENT EXPERIENCED INTOLERABLE GLARE AND STATED THAT THEY WANT TO HAVE AN IOL EXCHANGE AND REPLACE IT WITH THE LIGHT ADJUSTABLE LENS. THE VISUAL SYMPTOMS WERE NOTICED ONE DAY POST OPERATIVELY AND IMPROVED SLIGHTLY OVER 1 MONTH. THE PATIENT WAS DISSATISFIED WITH THE OUTCOME. CONSEQUENTLY, THE IOL WAS EXPLANTED. THE PATIENT IS DOING WELL. NO FURTHER INFORMATION IS AVAILABLE. A SEPARATE REPORT IS BEING SUBMITTED FOR THE LEFT EYE.

  Patient problems: Visual Disturbances

  MAUDE report 25116020 ↗
• MalfunctionApr 21, 2026Break

  DAMAGE ON OUTER EDGE OF THE DRN00V MODEL INTRAOCULAR LENS (IOL) WAS NOTED AFTER ITS IMPLANTATION IN THE PATIENT'S OPERATIVE EYE. THE IOL WAS LEFT IN PLACE AS THE DOCTOR DETERMINED THAT THE DAMAGE WOULD NOT IMPACT THE PATIENT'S VISION. IT IS SUSPECTED THAT THE DAMAGE MAY HAVE BEEN ATTRIBUTED TO THE PLUNGER TIP. PATIENT PROGNOSIS POST-PROCEDURE/ IS UNKNOWN. THE SUSPECT IOL IS NOT AVAILABLE FOR INVESTIGATION AS IT REMAINS IMPLANTED. THE INJECTOR COULD NOT BE PRESERVED FOR FURTHER INVESTIGATION AS IT HAD BEEN DISCARDED BY THE STAFF. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24948044 ↗
• 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 +18.0 DIOPTER. 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 24793439 ↗
• InjuryFeb 23, 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 EYE. THE PATIENT COMPLAINED OF DYSPHOTOPSIAS. THE IOL WAS EXPLANTED AND REPLACED WITH ANOTHER JNJ IOL MODEL ZCB00. THERE WERE NO SURGICAL OR MEDICAL INTERVENTIONS SUCH AS AN INCISION ENLARGEMENT, VITRECTOMY, SUTURES, MEDICATION PRESCRIBED TO PREVENT PERMANENT IMPAIRMENT. THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 24416007 ↗
• MalfunctionDec 26, 2025Break; Mechanical Problem; Mechanical Jam; Break; Mechanical Problem; Mechanical Jam

  IT WAS REPORTED THAT THE PLUNGER OF THE INJECTORS FOR TWO PRELOADED MULTIFOCAL INTRAOCULAR LENSES (IOLS) BECAME LODGED ABOVE AND TO THE SIDE OF THE LENS DURING USE. THERE WERE NO REPORTS OF CRACKED CARTRIDGES OR DAMAGED CARTRIDGE TIPS. ONE OUT OF TWO CASES RESULTED IN LENS DAMAGE WITH PATIENT CONTACT. THE OTHER CASE WAS CONFIRMED AS AN OVERRIDE EVENT ONLY, WITH NO PATIENT CONTACT. THE ACCOUNT IS OBSERVING THIS ISSUE IN MULTIPLE CASES AND REPORTS INCREASED RESISTANCE DURING INJECTION. THE FACILITY USES BOTH BSS AND OVD AT ROOM TEMPERATURE; THE TECHNICIAN PERFORMS THE INITIAL TURN OF THE INJECTOR, AND THE SURGEON COMPLETES THE FINAL TURN. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT PERTAINS TO THE EVENT OF LENS DAMAGE WITH PATIENT CONTACT REPORTED WITH THE LENS MODEL DRN00V, SN (B)(6). THE OTHER INCIDENTS DO NOT MEET THE REPORTABILITY CRITERIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23900948 ↗
• MalfunctionDec 12, 2025Contamination; Contamination

  IT WAS REPORTED THAT DURING A PROCEDURE THE DOCTOR IDENTIFIED AN OFF-WHITE FIBER IN THE PRELOADED DELIVERY SYSTEM OF A PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL). THE FIBER WAS REMOVED AND THE LENS WAS IMPLANTED. IT WAS CONFIRMED THAT THE LENS REMAINED IMPLANTED AND NO MATERIALS WERE RETAINED FOR RETURN. NO PATIENT IMPACT WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23786646 ↗
• MalfunctionNov 26, 2025Break; Operating System Becomes Nonfunctional; Break; Operating System Becomes Nonfunctional

  IT WAS REPORTED THAT DURING THE IMPLANTATION OF A PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL), THE PLUNGER CAUGHT ON THE LENS, CAUSING DAMAGE TO THE LENS. THE CARTRIDGE TIP CAME INTO CONTACT WITH THE PATIENT'S EYE, AND THE LENS WAS INSERTED AND REMOVED DURING THE SAME PROCEDURE. A REPLACEMENT LENS OF THE SAME MODEL AND DIOPTER WAS USED. THE ISSUE DID NOT AFFECT PATIENT'S DAILY ACTIVITIES. THERE WAS NO UNPLANNED INCISION ENLARGEMENT, SUTURES, OR VITRECTOMY, AND NO DELAY IN THE PROCEDURE OCCURRED. THE DIRECTIONS FOR USE WERE FOLLOWED, AND NO ADDITIONAL MEDICAL ATTENTION OR MEDICATION OUTSIDE OF STANDARD CARE WAS REQUIRED. THE PATIENT HAS FULLY RECOVERED AND NO PATIENT INJURY REPORTED. A NON-JOHNSON & JOHNSON LUBRICATION WAS USED WHICH WAS INTRODUCED INTO THE CARTRIDGE CANOPY. NO COMBINATION OF BALANCED SALT SOLUTION (BSS) AND OPHTHALMIC VISCOELASTIC DEVICE (OVD) WAS USED. THE AVERAGE DWELL TIME/KEEP IN THE DWELL POSITION WAS STATED TO BE LESS THAN A MINUTE AND THEY INITIALLY ADVANCED THE LENS BY PUSHING PLUNGER SLOWLY, START SCREWING DOWN WITH MINIMAL FORCE. THE SCRUB TECH IS THE PERSON WHO DOES THE INITIAL MOVEMENT OF THE LENS/FIRST TWIST AND IT IS UNINTERRUPTED ONCE THE LENS PASSED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23660522 ↗
• MalfunctionNov 14, 2025Scratched Material; Scratched Material

  IT WAS REPORTED THAT AFTER THE PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) WAS FULLY IMPLANTED IN THE PATIENT¿S RIGHT EYE, IT WAS NOTICED THAT THE LENS WAS SCRATCHED FROM THE INSERTER. THE LENS WAS SUBSEQUENTLY REMOVED AND REPLACED DURING THE SAME PROCEDURE WITHOUT ANY HARM TO THE PATIENT. NO UNPLANNED INTERVENTIONS, SUCH AS INCISION ENLARGEMENT, SUTURES, OR VITRECTOMY, AND NO MEDICATION OR MEDICAL ATTENTION BEYOND THE STANDARD CARE WAS REQUIRED. THERE WAS NO DELAY IN THE PROCEDURE. DAILY ACTIVITIES WERE NOT SIGNIFICANTLY AFFECTED. DIRECTIONS FOR USE WERE FOLLOWED. THE PATIENT IS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23560233 ↗
• MalfunctionSep 9, 2025Break; Device Difficult to Setup or Prepare; Break; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT DURING THE USE OF THE PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL), SLIGHT RESISTANCE WAS OBSERVED. SUBSEQUENT EXAMINATION UNDER A MICROSCOPE REVEALED THAT THE LENS WAS SPLIT IN HALF. THE LENS AND CARTRIDGE HAD COME INTO CONTACT WITH THE RIGHT EYE, BUT THE DEFECT WAS IDENTIFIED BEFORE THE LENS WAS FULLY INSERTED. THE INJECTOR WAS RETRACTED WITHOUT COMPLETING THE INSERTION. THE PROCEDURE WAS COMPLETED USING A BACKUP LENS WITH THE SAME MODEL AND DIOPTER. THERE WERE NO INJURIES OR COMPLICATIONS, SUCH AS CAPSULE TEAR, UNPLANNED VITRECTOMY, INCISION ENLARGEMENT, OR THE NEED FOR SUTURES. NO MEDICATION OUTSIDE THE STANDARD OF CARE WAS REQUIRED. THE CUSTOMER REPORTED THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23004934 ↗
• InjuryAug 24, 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 FROM THE PATIENT¿S LEFT EYE. THE EXPLANT WAS PERFORMED BECAUSE THE PATIENT EXPERIENCED MYOPIC SURPRISE WHICH WAS NOTICED APPROXIMATELY ONE WEEK POST IMPLANTATION. THE REPLACEMENT LENS WAS THE SAME JNJ MODEL DRN00V AND DIFFERENT DIOPTER 18.5. THERE WERE NO COMPLICATIONS, SUCH AS A CAPSULE TEAR, VITRECTOMY, OR SUTURES, AND NO PRODUCT-RELATED ISSUES WERE IDENTIFIED. THE PATIENT IS DOING WELL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 22881557 ↗
• MalfunctionAug 5, 2025Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT AFTER IMPLANTING THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) INTO THE PATIENT'S LEFT EYE IT WAS FOUND TO BE DEFECTIVE. THE IOL WAS IMMEDIATELY REMOVED AND REPLACED WITH A NEW LENS OF THE SAME MODEL DRN00V 19.0 DIOPTER. THERE WERE NO COMPLICATIONS SUCH AS A VITRECTOMY, INCISION ENLARGEMENT OR SUTURES. THE PATIENT¿S OUTCOME WAS REPORTED AS STABLE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22720575 ↗
• MalfunctionJul 1, 2025Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT AN ODYSSEY 19 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED BECAUSE THE LENS WAS DAMAGED. SURGEON HAD IMPLANTED THE LENS NICELY BUT ONCE IT WAS IN, HE SAW A HUGE CRACK IN THE LENS AND THEN IT WAS EXPLANTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22378879 ↗
• MalfunctionJun 4, 2025Scratched Material; Scratched Material

  T 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 22146185 ↗
• InjuryMay 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE LENS WAS EXPLANTED DUE TO THE PATIENT COMPLAINING OF BLURRINESS AT 8 FEET, HALOS DURING THE DAYTIME AND SIGNIFICANT NIGHTTIME HALOS AROUND BRIGHT LIGHTS. THE LENS WAS REMOVED AND REPLACED DURING A SECONDARY SURGICAL PROCEDURE WITH A NON-J&J LENS. NO INJURY OR ADDITIONAL INTERVENTION WAS REQUIRED. THE PATIENT IS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 22038243 ↗
• InjuryMar 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO THE PATIENT EXPERIENCING GLARE AND HALOS. IT WAS REMOVED AND REPLACED DURING A SECONDARY SURGICAL PROCEDURE WITH A LENS FROM ANOTHER MANUFACTURER. THERE WAS NO INJURY AND NO INTERVENTION WAS REQUIRED. THE PATIENT IS WELL WITH A VISION OF 20/30 AFTER 1 DAY POST-OPERATIVE.. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 21712689 ↗
• MalfunctionMar 25, 2025Scratched Material; Scratched Material

  IT WAS REPORTED BY THE SURGEON THAT THE INSERTER OF THE PRELOADED INTRAOCULAR LENS (IOL) COULD NOT FIT THROUGH THE 2.4 INCISION IN THE RIGHT EYE OF THE PATIENT. THE INCISION WAS ENLARGED AND IOL WAS IMPLANTED. HOWEVER, THE LENS WAS FOUND TO BE SCRATCHED. THE PATIENT IS FINE AND THE IOL REMAINS IMPLANTED IN THE PATIENT'S EYE; THERE ARE NO PLANS TO EXPLANT THE DEVICE. THERE WERE NO MEDICAL/SURGICAL INTERVENTION REQUIRED. THE PATIENT IS DOING FINE. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 21690508 ↗
• MalfunctionDec 11, 2024Break; Break

  IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) HAD A DEFECT. THE DEFECT WAS OBSERVED BY THE SURGEON AT THE 3 O¿CLOCK POSITION OF THE OPTIC DURING THE IMPLANTATION PROCEDURE. DESPITE THE DEFECT, THE DECISION WAS MADE TO LEAVE THE IMPLANT IN THE EYE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20910047 ↗
• InjuryAug 15, 2024Adverse 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 THE PATIENT'S RIGHT EYE AS THE PATIENT WAS COMPLAINING OF GLARES. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. FROM ADDITIONAL INFORMATION IT WAS LEARNT THAT THERE WERE OTHER VISUAL ISSUES LIKE GLARE AND BLURRED VISION AFTER MONOFOCAL LENS, THERE WAS IMPROVEMENT IN THE VISION OF THE PATIENT WITH THE REPLACEMENT LENS POST-IOL EXCHANGE. THE PATIENT IS DOING WELL BUT STILL WITH MILD DRYNESS. THERE WERE NO DEBILITATING CONDITIONS IN THE PATIENT, BUT PATIENT DID WANT TO EXCHANGE HIS ODYSSEY. THE PATIENT'S DAILY ACTIVITIES WERE AFFECTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Dry Eye(s); Visual Disturbances

  MAUDE report 19996162 ↗
• MalfunctionJul 2, 2024Crack; Device Difficult to Setup or Prepare; Crack; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT A BACK-UP INTRAOCULAR LENS (IOL) WAS OPENED. THE TECH FELT SOME RESISTANCE DURING LOADING. THE SURGEON BEGAN TO DEPLOY THE IOL AND NOTICED THAT THE TIP OF THE CARTRIDGE WAS TORN. NO PATIENT HARM, SURGEON PROCEEDED TO IMPLANT (NO EXPLANATION). NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19661299 ↗