TECNIS ODYSSEY IOL DRN00V (REF DRN00V0115)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474810594), received between Sep 17, 2024 and Jan 7, 2026 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJan 7, 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 RIGHT EYE. DURING A POST-OPERATIVE EXAMINATION, THE PATIENT REPORTED VISUAL DISTURBANCES, INCLUDING SHADOWS OR "AURAS" AROUND LETTERS AND WORDS, UNCLEAR DISTANCE AND NEAR VISION, DIFFICULTY READING, HALOS AROUND LIGHTS, AND GLARE. THE PATIENT¿S PRE-OPERATIVE VISION WAS RECORDED AS 20/50 - 2, WHILE POST-OPERATIVE VISION WAS NOTED AS 20/30. MEDICAL ATTENTION WAS SOUGHT, AND PREDNISOLONE ACETATE WAS PRESCRIBED. THE IOL WAS SUBSEQUENTLY EXPLANTED. THERE WERE NO SUTURES OR VITRECTOMY REQUIRED. NO FURTHER INFORMATION IS AVAILABLE REGARDING THIS EVENT.

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

  MAUDE report 23999100 ↗
• MalfunctionOct 16, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT TWO SINGLE PIECE PRELOADED MULTIFOCAL INTRAOCULAR LENSES (IOL) TORE DURING INSERTION INTO THE PATIENT¿S LEFT EYE. BOTH LENSES WERE FULLY INSERTED AND THEN CUT IN HALF IN THE EYE AND REMOVED DURING THE SAME PROCEDURE. THIS LED TO A DELAY IN THE PROCEDURE BY APPROXIMATELY 15-20 MINUTES. NO MEDICATION OUTSIDE THE STANDARD OF CARE WAS REQUIRED. THERE WAS NO UNPLANNED INCISION ENLARGEMENT, UNPLANNED VITRECTOMY, OR UNPLANNED SUTURES. NO PATIENT INJURY WAS REPORTED. DAILY ACTIVITIES WERE NOT AFFECTED. THE PATIENT¿S STATUS FOLLOWING THE EVENT IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS TO CAPTURE THE EVENT FOR DRN00V 11.5 DIOPTER, SERIAL NUMBER (B)(6). A SEPARATE REPORT WILL BE FILED TO CAPTURE THE EVENT FOR DRN00V 11.5 DIOPTER, SERIAL NUMBER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23317894 ↗
• MalfunctionOct 16, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT TWO SINGLE PIECE PRELOADED MULTIFOCAL INTRAOCULAR LENSES (IOL) TORE DURING INSERTION INTO THE PATIENT¿S LEFT EYE. BOTH LENSES WERE FULLY INSERTED AND THEN CUT IN HALF IN THE EYE AND REMOVED DURING THE SAME PROCEDURE. THIS LED TO A DELAY IN THE PROCEDURE BY APPROXIMATELY 15-20 MINUTES. NO MEDICATION OUTSIDE THE STANDARD OF CARE WAS REQUIRED. THERE WAS NO UNPLANNED INCISION ENLARGEMENT, UNPLANNED VITRECTOMY, OR UNPLANNED SUTURES. NO PATIENT INJURY WAS REPORTED. DAILY ACTIVITIES WERE NOT AFFECTED. THE PATIENT¿S STATUS FOLLOWING THE EVENT IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS TO CAPTURE THE EVENT FOR DRN00V 11.5 DIOPTER, SERIAL NUMBER (B)(6). A SEPARATE REPORT WILL BE FILED TO CAPTURE THE EVENT FOR DRN00V 11.5 DIOPTER, SERIAL NUMBER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23317862 ↗
• InjuryMay 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING THE PRELOADED INTRAOCULAR LENS (IOL) IMPLANTATION IN THE PATIENT'S RIGHT EYE, THE PATIENT COMPLAINED OF BEING UNABLE TO SEE WELL AT A DISTANCE. THE IOL WAS EXPLANTED AND A SYNERGY IOL WAS IMPLANTED. NO PATIENT INJURY WAS REPORTED. NO OTHER MEDICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 21988748 ↗
• MalfunctionSep 17, 2024Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS(IOL) WAS IMPLANTED AND THE LENS CAME OUT SCRATCHED OR WITH MARKS ON IT IN THE EYE. THE LENS WAS REMOVED AND REPLACED WITH THE THE BACK UP LENS IN THE SAME PROCEDURE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20242389 ↗