TECNIS ODYSSEY IOL DRN00V (REF DRN00V0150)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474810662), received between Oct 1, 2024 and Feb 24, 2026 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (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.

• MalfunctionFeb 24, 2026Mechanical Problem; Scratched Material

  IT WAS REPORTED THAT THE PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) BECAME SCRATCHED WHEN THE LOADER ADVANCED THE LENS. THE CARTRIDGE TIP WAS NOT DAMAGED. THE HAPTIC OR OPTIC OF THE LENS WAS DAMAGED DURING ADVANCEMENT. NO RESISTANCE WAS NOTED, AND THE USER DID NOT APPLY FORCE WHILE DELIVERING THE LENS. THE LENS AND CARTRIDGE DID NOT COME INTO CONTACT WITH THE PATIENT. THE PROCEDURE WAS COMPLETED USING A BACKUP/REPLACEMENT IOL. NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTIONS SUCH AS VITRECTOMY, INCISION ENLARGEMENT, OR SUTURING WERE REQUIRED. NO PATIENT INJURY, INCLUDING CAPSULAR TEAR, WAS REPORTED. THE PATIENT OUTCOME STATUS WAS RECORDED AS ¿BOARDED CATARACT.¿ THE DEVICE WAS SUBSEQUENTLY DISPOSED OF BY STAFF. IT WAS NOTED THAT BALANCED SALT SOLUTION (BSS) WAS USED AS THE CARTRIDGE LUBRICANT AND WAS APPLIED AT ROOM TEMPERATURE. NO ADDITIVES WERE USED. THE BSS WAS INTRODUCED INTO THE CARTRIDGE VIA THE CANOPY. THE INITIAL MOVEMENT OF THE LENS IS PERFORMED BY A TECHNICIAN, AND THE FIRST TWIST IS PERFORMED BY THE SURGEON. NO FURTHER INFORMATION WAS PROVIDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24434447 ↗
• InjuryAug 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE GLARE AND HALOS AFTER THE IMPLANTATION OF A PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL). ADDITIONAL INFORMATION INDICATED THAT THE GLARE AND HALOS BEGAN ONE DAY AFTER THE SURGERY. THE PATIENT UNDERWENT DRY EYE TREATMENT, USED GLARE-RESISTANT GLASSES, AND RECEIVED YTTRIUM-ALUMINUM-GARNET (YAG) LASER CAPSULOTOMY; HOWEVER, THESE INTERVENTIONS DID NOT RESOLVE THE ISSUE. THE PATIENT SUBSEQUENTLY SOUGHT A REFERRAL TO ANOTHER CLINIC AND HAD LENS EXPLANTED. NO OTHER INFORMATION WAS PROVIDED. THE PATIENT UNDERWENT BILATERAL LENS IMPLANTATION. THIS EMDR REPORT DETAILS THE ISSUES REPORTED CONCERNING THE RIGHT EYE. A SEPARATE MDR WILL BE SUBMITTED TO ADDRESS THE ISSUES REPORTED WITH THE LEFT EYE.

  Patient problems: Dry Eye(s); Halo; Visual Disturbances

  MAUDE report 22929489 ↗
• MalfunctionJul 20, 2025Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE PRE-LOADED INTRAOCULAR LENS (IOL) HAD A SCRATCH ON THE SURFACE WHEN IT WAS INJECTED INTO THE EYE. THE IOL WAS REMOVED AND REPLACED WITH ANOTHER LENS. SURGERY WAS COMPLETED IN THE SAME PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22552186 ↗
• MalfunctionJun 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT OF DEFECTIVE PRELOADED INTRAOCULAR LENS (IOL) AND PLANNED EXPLANT WAS RECEIVED NOTING THAT PATIENT'S DAILY ACTIVITIES WERE SIGNIFICANTLY AFFECTED POST OPERATIVELY. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE LENS WAS EXPLANTED AND REPLACED WITH AN UNKNOWN 13.0 DIOPTER IOL. FURTHER INFORMATION WAS RECEIVED EXPLAINING THAT THE INITIALLY REPORTED DEFECTIVE IOL WAS DUE TO PATIENT NOT SEEING WELL AFTER THE IMPLANT. REPORTEDLY IOL WAS EXCHANGED AND THERE WERE NO VISIBLE DEFECTS WITH LENS. THE PATIENT IS DOING WELL AFTER THE EXCHANGE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 22207447 ↗
• InjuryOct 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MULTIFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT¿S RIGHT EYE DUE TO RESIDUAL REFRACTIVE ERROR, IRREGULAR CORNEAL ASTIGMATISM SECONDARY TO LASIK. PATIENT VISUAL CONCERNS WERE UNSAFE DISTANCE VISION, NOT GETTING FUNCTIONAL NEAR VISION, UNDERWHELMING VISION. A DIFFERENT JOHNSON & JOHNSON LENS, MONOFOCAL IOL, MODEL DIB00 OF A LOWER DIOPTER (14.5D) WAS USED AS A REPLACEMENT WHICH HELPED ADDRESSING THE PATIENT'S VISUAL CONCERNS. NO INCISION ENLARGEMENT, NO VITRECTOMY AND NO SUTURES REQUIRED. THE ACCOUNT THINKS THAT THE DEVICE WAS DISPOSED OF. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 20341094 ↗