TECNIS ODYSSEY IOL DRN00V (REF DRN00V0245)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474810853), received between Mar 26, 2024 and Sep 28, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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.

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

  Patient problems: Eye Injury

  MAUDE report 50926511 ↗
• InjuryJun 3, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT A PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S RIGHT EYE. POSTOPERATIVELY, THE PATIENT WAS NOTED TO BE MYOPIC AT APPROXIMATELY -0.75 TO -1.00 DIOPTERS. THE PHYSICIAN CONFIRMED THAT THE PREOPERATIVE IOL MASTER MEASUREMENTS AND CALCULATIONS WERE PERFORMED APPROPRIATELY. DUE TO THE REFRACTIVE OUTCOME, AN IOL EXCHANGE WAS PLANNED, WITH CONSIDERATION FOR IMPLANTATION OF AN ODYSSEY LENS OF +23.5 DIOPTER POWER. A CONTACT LENS TRIAL AT PLANO WAS CONDUCTED, WHICH THE PATIENT TOLERATED WELL. THE ORIGINAL IOL WAS SUBSEQUENTLY EXPLANTED ON (B)(6) 2026. NO PATIENT OR USER HARM WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 25385865 ↗
• InjuryJun 2, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED REGARDING THE JOHNSON (JNJ) INTRAOCULAR LENS (IOL). THE PATIENT¿S HUSBAND CALLED TO REPORT THAT HIS WIFE HAS A JOHNSON AND JOHNSON IOL IMPLANTED IN BOTH EYES. THIS REPORT IS FOR THE LEFT EYE. DURING THE INITIAL PHONE CALL HIS WIFE (THE PATIENT) JOINED THE CONVERSATION. DURING A FOLLOW-UP PHONE CALL ONLY, THE HUSBAND SPOKE ABOUT THE ISSUES EXPERIENCED BY HIS WIFE. THE FOLLOWING SUMMARY OF THE EVENT COMBINES INFORMATION FROM BOTH CONVERSATIONS. AFTER THE IOLS WERE IMPLANTED THE PATIENT REPORTED HAVING ISSUES. THE PATIENT SEES CLEARLY DURING THE DAY. HER DISTANCE VISION IS ¿WONDERFUL¿. THE MAIN COMPLAINT IS HALOS AT NIGHT THAT INTERFERE WITH THEIR DEPTH PERCEPTION TO THE POINT WHERE SHE CANNOT DRIVE AT NIGHT. THE PATIENT ONLY DRIVES DURING THE DAY DUE TO THE HALOS. THE PATIENT ANTICIPATED A FULL RANGE OF VISION WITHOUT GLASSES. HOWEVER, THE PATIENT NEEDS PRESCRIPTION GLASSES AND A MAGNIFYING GLASS TO READ. SHE CANNOT READ MORE THAN 5 MINUTES AT A TIME, AND THIS HAS PERSISTED SINCE HER IMPLANTS. THE DOCTOR SAID HER VISION IS 20/20. THE HUSBAND BELIEVES THAT BECAUSE THE IOL IS DESIGNED FOR FULL RANGE VISION, HIS WIFE SHOULD NOT REQUIRE PRESCRIPTION GLASSES FOR

  Patient problems: Discomfort; Halo

  MAUDE report 25364280 ↗
• 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 RIGHT EYE. A SEPARATE REPORT WILL BE SUBMITTED FOR THE LEFT EYE.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 24809548 ↗
• InjuryMar 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS INITIALLY REPORTED THAT AN INTRAOCULAR LENS (IOL), MODEL DRN 23.0 WAS EXPLANTED FROM A PATIENT¿S RIGHT EYE (OD) DUE TO HYPEROPIC SURPRISE. THE REPLACEMENT LENS WAS OF THE SAME MODEL BUT OF A HIGHER DIOPTER (24.5D). NO SURGICAL AND/OR MEDICAL INTERVENTIONS REQUIRED, AND NO PATIENT INJURY REPORTED. BEFORE THE EXPLANT OF THE ORIGINAL LENS THE PATIENT¿S CORRECT AND UNCORRECTED VISUAL ACUITY WAS 20/25 BLURRY/ BEST CORRECTED 20/15. IN FOLLOW UPS, IT WAS LEARNED THAT YTTRIUM-ALUMINUM-GARNET (YAG) LASER PROCEDURE WAS PERFORMED ON (B)(6) 2024, SOME DAYS AFTER THE REPLACEMENT LENS WAS IMPLANTED IN OD. IT WAS INDICATED THAT THE PATIENT HAD POSTERIOR CAPSULAR OPACIFICATION (PCO) AND THE YAG PERFORMED WAS MAINLY DONE IN PREPARATION FOR TOUCH UP. THE PATIENT HAD A FILM OVER IN OD VISION. THE SYMPTOMS TO SOME DEGREE IMPACTED THE PATIENT'S VISUAL FUNCTION; HOWEVER, IT WAS NOTED THAT THE PATIENT¿S ISSUE WAS NOT DUE TO JOHNSON & JOHNSON DEVICE. PATIENTS LAST VISION WAS: VISUAL ACUITY WITH DISTANT WITHOUT CORRECTION (DSC) 20/40+1. PINHOLE (PH) 20/25-1. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT PERTAINS TO THE ISSUES REPORTED ON THE REPLACEMENT LENS. THE ISSUES REPORTED ON THE ORIGINAL L

  Patient problems: Posterior Capsule Opacification; Visual Impairment

  MAUDE report 18976523 ↗