TECNIS ODYSSEY IOL DRN00V (REF DRN00V0160)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05050474810686), received between Dec 22, 2023 and Apr 14, 2026 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  THE DRN00V MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S EYE. POST-OPERATIVELY, VISUAL OUTCOMES DID NOT MEET STANDARD AND THE PATIENT WAS UNHAPPY, THUS THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A DRN00V 17.5 IOL. THERE WAS NO MEDICAL INTERVENTION REQUIRED DURING THE EXPLANT PROCEDURE. PATIENT PROGNOSIS POST LENS EXCHANGE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Discomfort; Visual Impairment

  MAUDE report 24879303 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE CUSTOMER THAT FOLLOWING IMPLANTATION OF A PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL), MODEL DRN00V, IN THE PATIENT¿S RIGHT EYE, THE PATIENT EXPERIENCED SEVERE NIGHTTIME HALOS AND AVOIDED DRIVING AT NIGHT. BEST-CORRECTED VISUAL ACUITY (BCVA) REMAINED SUBOPTIMAL, AND THE PATIENT WAS DEEMED AN UNSUITABLE CANDIDATE FOR A MULTIFOCAL LENS. THE LENS WAS EXPLANTED DURING A SECONDARY PROCEDURE AND REPLACED WITH A NON-JOHNSON & JOHNSON LENS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT COMPLICATIONS SUCH AS VITRECTOMY, INCISION ENLARGEMENT, SUTURES, OR ADDITIONAL MEDICATIONS BEYOND STANDARD CARE. THE CUSTOMER BELIEVES THE DEVICE CONTRIBUTED TO THE EVENT. THE PATIENT¿S OUTCOME WAS GOOD, WITH NO IMPACT ON DAILY ACTIVITIES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 24063310 ↗
• MalfunctionDec 1, 2025Break; Device Difficult to Setup or Prepare; Break; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT DURING IMPLANTATION OF A PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL), MODEL DRN00V, INTO THE PATIENT¿S RIGHT EYE, THE SURGEON EXPERIENCED DIFFICULTY ADVANCING THE LENS. THE SHOOTER CAUSED A CRACK ON THE SIDE OF THE LENS; THEREFORE, THE LENS WAS CUT AND REMOVED FROM THE EYE. A REPLACEMENT LENS OF THE SAME MODEL WAS SUCCESSFULLY IMPLANTED WITHOUT COMPLICATIONS. NO ADDITIONAL INTERVENTIONS SUCH AS VITRECTOMY, SUTURES, OR INCISION ENLARGEMENT WERE REQUIRED. THE PATIENT¿S POSTOPERATIVE STATUS WAS REPORTED AS WITH NO CONCERNS. THE COMPLAINT DEVICE WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23687639 ↗
• InjuryOct 23, 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 LENSES (IOL) WERE IMPLANTED IN BOTH EYES DURING CATARACT SURGERY, THE PATIENT WAS NOT HAPPY WITH THE LENSES AND EXPERIENCED BLURRINESS. THE PATIENT, WHO WORKS AS AN ELECTRICIAN, REPORTED DIFFICULTY SEEING WIRES UP CLOSE, WHICH HAS AFFECTED DAILY ACTIVITIES. THE PATIENT WAS ASSESSED AS UNDER-CORRECTED WITH NO LOSS OF TWO OR MORE LINES OF BEST SPECTACLE CORRECTED VISUAL ACUITY (BSCVA). PRE-OPERATIVE REFRACTION WAS -2.00 -0.50 X 155 WITH A BSCVA OF 20/20-2, WHILE POST-OPERATIVE REFRACTION WAS -0.25 D.S. WITH A BSCVA OF 20/30. THE INTENDED TARGET REFRACTION WAS PLANO. A HISTORY OF LASER-ASSISTED INTRASTROMAL KERATOMILEUSIS (LASIK) WAS NOTED AS A PRE-EXISTING CONDITION THAT INFLUENCED THE LENS CALCULATION. THERE WAS NO INJURY REPORTED. THE SURGEON HAS DECIDED TO PERFORM A LENS EXCHANGE, THOUGH THE PROCEDURE HAS NOT YET BEEN SCHEDULED. THE LENS REMAINS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS TO CAPTURE THE LEFT EYE EVENT. A SEPARATE REPORT WILL BE SUBMITTED TO CAPTURE THE RIGHT EYE EVENT.

  Patient problems: Blurred Vision

  MAUDE report 23372230 ↗
• MalfunctionMay 29, 2025Crack; Crack

  IT WAS REPORTED THAT A PRELOADED LENS HAD A FAULTY CARTRIDGE. THE PATIENT CONTACTED WITH LENS. THE LENS CAME OUT SIDEWAYS, AND THE TIP OF THE CARTRIDGE WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER IOL OF THE SAME MODEL (J&J). THE PATIENT WAS DOING WELL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22107158 ↗
• InjuryMay 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRE-LOADED INTRAOCULAR LENS WAS EXPLANTED FROM PATIENT'S LEFT EYE IN A SECONDARY SURGICAL PROCEDURE BECAUSE PATIENT COMPLAINED OF FOGGY VISION, HALOING AND VERTICAL DOUBLING AT A DISTANCE. THERE WAS A MYOPIC MISS OF 0.375 DIOPTER. INCISION ENLARGEMENT, SUTURE AND VITRECTOMY WERE NOT REQUIRED AND THERE WAS NO DELAY IN PROCEDURE. DIRECTIONS FOR USE WERE FOLLOWED. THERE WAS A MYOPIC MISS OF 0.375 DIOPTER. PATIENTS PRE-OP BEST CORRECTED VISUAL ACUITY (BSCVA) WAS 20/25 +2 AND POST OP BSCVA WAS 20/20 -2. PATIENT WAS FULLY RECOVERED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Halo; Visual Impairment

  MAUDE report 22075155 ↗
• 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 SHADOWING OF LETTERS, STREAKING OF LIGHTS AND GLARE WHEN DRIVING AT NIGHT, HALOS AROUND AND PINPOINTS OF LIGHT, DARKER/HAZY PERIPHERAL VISON. THE LENS WAS REMOVED AND REPLACED DURING A SECONDARY SURGICAL PROCEDURE WITH A NON-J&J LENS. THERE WAS NO INJURY AND NO FURTHER INTERVENTION WAS REQUIRED. THE PATIENT FULLY RECOVERED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Flashers; Halo; Visual Disturbances

  MAUDE report 22039703 ↗
• 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 18383964 ↗