TECNIS ODYSSEY IOL DRN00V (REF DRN00V0250)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05050474810860), received between Mar 14, 2025 and Aug 5, 2026 — classified as 7 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 2026Scratched Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50145033 ↗
• InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT A PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S RIGHT EYE. POSTOPERATIVELY, THE PATIENT EXPERIENCED POOR NEAR VISION, AND REFRACTION REVEALED APPROXIMATELY +0.75 DIOPTERS (D) OF HYPEROPIA. THE PHYSICIAN PLANNED TO EXPLANT THE LENS AND REPLACE IT WITH THE SAME IOL MODEL AT A HIGHER DIOPTER POWER (26.0 D). ADDITIONAL INFORMATION INDICATED THAT THE EXPLANT PROCEDURE WAS COMPLETED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 24836325 ↗
• InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED HALOS AND GLARE FOLLOWING THE IMPLANTATION OF PRELOADED MULTIFOCAL INTRAOCULAR LENSES (IOLS) IN BOTH EYES. THE LENSES WERE SUBSEQUENTLY REPLACED WITH NON-PRELOADED MONOFOCAL INTRAOCULAR LENSES, MODEL ZCB00. NO HARM TO THE PATIENT OR USER WAS REPORTED. IT WAS NOTED THAT THE PRODUCTS ARE UNAVAILABLE FOR RETURN TO BE EVALUATED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT CAPTURES THE ISSUES WITH THE PATIENT'S LEFT EYE. A SEPARATE REPORT WILL BE SUBMITTED FOR THE RIGHT EYE.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 24809603 ↗
• InjuryApr 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE LEFT EYE DUE TO AN UNKNOWN REASON. THE REPLACEMENT LENS WAS ANOTHER JOHNSON AND JOHNSON (DRN00V 22.0). THE DOUVISC WAS USED AS VISCOELASTIC. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 24793471 ↗
• MalfunctionDec 19, 2025Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT NEARLY THE ENTIRE PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) HAD BEEN DELIVERED INTO THE PATIENT'S EYE WHEN THE TRAILING HAPTIC BECAME CAUGHT IN THE INSERTER PLUNGER AND TORE. THE SURGEON REMOVED THE DAMAGED LENS AND IMPLANTED A BACKUP IOL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23858092 ↗
• InjuryMay 21, 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. THE PATIENT WAS EXPERIENCING BOTHERSOME SIDE EFFECTS. THIS MAY HAVE BEEN EXACERBATED BY THE PATIENT ENDING UP SOMEWHAT OVER MINUSED. THERE WERE NO COMPLICATIONS REPORTED. THE IOL WAS REPLACED WITH AN ALCON MONOFOCAL LENS 23.5 DIOPTER. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 22058280 ↗
• InjuryApr 18, 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 WRONG POWER. THE PROCEDURE WAS COMPLETED WITH A NEW, DIFFERENT MODEL AND DIOPTER (DRT00) LENS DURING A SECONDARY SURGICAL PROCEDURE. NO INJURY OR MEDICAL INTERVENTION WAS REQUIRED. THERE IS NO INFORMATION ABOUT THE PATIENT'S VISUAL OUTCOME. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 21867703 ↗
• InjuryMar 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A POST-OPERATIVE EXAMINATION ON FEBRUARY 18TH FOLLOWING IMPLATATION OF A PRELOADED INTRAOCULAR LENS (IOL), THE PATIENT'S DEGREE OF MYOPIA SHIFTED. IT WAS NOTED THAT IT WAS DIFFICULT FOR THE PATIENT TO SEE. THE DISTANCE VISION IMPROVED WITH 1.0D CORRECTION, AND THE PATIENT'S DISSATISFACTION WAS ALSO RESOLVED. THROUGH FOLLOW-UP, WE LEARNED THAT ON FEBRUARY 20TH THE PHYSICIAN ATTEMPTED TO EXPLANT THE LENS. HOWEVER, DUE TO ADHESION BETWEEN THE LENS AND CAPSULE, THE IOL WAS LEFT IN PLACE AND THERE IS NO EXPLANT PLANNED IN THE FUTURE. THE ACCOUNT ALSO INDICATED THAT THE PLAN IS TO ADD ANOTHER LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 21660022 ↗
• InjuryMar 14, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A MULTIFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT'S RIGHT EYE DUE TO MECHANICAL FAILURE. NEW INCISION WAS MADE, THE LENS WAS TAKEN OUT WHOLE AND A NEW IOL WAS IMPLANTED IN THE SULCUS. NO SUTURES, NO VITRECTOMY, AND NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Visual Disturbances

  MAUDE report 21612838 ↗