TECNIS ODYSSEY IOL DRN00V (REF DRN00V0260)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474810884), received between Dec 11, 2024 and Sep 28, 2026 — classified as 3 injuries, 1 malfunction.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Eye Injury

  MAUDE report 50926574 ↗
• InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem

  THE PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL), MODEL DRN00V, WAS REPORTEDLY EXPLANTED FOR AN UNSPECIFIED REASON AND REPLACED WITH ANOTHER ODYSSEY IOL OF THE SAME MODEL WITH A 1-DIOPTER HIGHER POWER. NO FURTHER CLINICAL DETAILS OR ADDITIONAL INFORMATION REGARDING THE REASON FOR EXPLANTATION OR PATIENT OUTCOME WERE PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 24492359 ↗
• InjuryJan 27, 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 LEFT EYE. THE CUSTOMER REPORTED A REFRACTIVE SURPRISE AS THE PATIENT CAME MORE MYOPIC THAN EXPECTED. THE IOL WAS CHOSEN PER POST MYOPIC LASIK CALCULATIONS. HOWEVER, THE PATIENT ENDED UP WITH -1.75D MYOPIA UNEXPECTEDLY. THE CALCULATIONS WERE RE-DONE WITH BOTH ASCRS (AMERICAN SOCIETY OF CATARACT AND REFRACTIVE SURGERY) AND THE BARRETT TRUE K CALCULATORS. THE DOCTOR REIMAGED IOLM ((INTELLIGENT OPTICAL LINK MAPPER) ) AND TOPOGRAPHY, HAD TWO OTHER SURGEONS REVIEW PAPERWORK, TOPOGRAPHY, CALCULATIONS ETC¿ AND IT IS UNCLEAR WHERE THE ERROR HAS BEEN MADE. THE IMPLANTED LENS IS ALSO CORRECT. THE DOCTOR DISCUSSED THE ISSUE WITH THE PATIENT AT LENGTH. ADDITIONALLY, THE PATIENT HAS EXPERIENCED DIFFICULTY WITH WORK AND DRIVING DUE TO THE REFRACTIVE OUTCOME. AS A RESULT, THE PATIENT AND PHYSICIAN PLANNED TO EXPLANT THE IOL AND REPLACE IT WITH ANOTHER JOHNSON AND JOHNSON IOL MODEL ODYSSEY +24.5D DIOPTER MFIOL (MULTIFOCAL INTRAOCULAR LENS). THE IOL WAS SUBSEQUENTLY EXPLANTED, HOWEVER, THE EXACT REPLACEMENT IOL INFORMATION WAS NOT PROVIDED. DURING THE PROCEDURE THERE WERE NO COMPLICAT

  Patient problems: Visual Impairment

  MAUDE report 24196605 ↗
• MalfunctionDec 11, 2024Break; Break

  IT REPORTED THAT THE HAPTIC OF THE PRELOADED INTRAOCULAR LENS (IOL) WAS BROKEN DURING SURGERY. THE LENS WAS REMOVED AND REPLACED WITH THE BACK UP LENS DUE TO FAULTY LENS IN THE SAME PROCEDURE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20908105 ↗