TECNIS ODYSSEY IOL DRN00V (REF DRN00V0155)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474810679), received between Feb 13, 2025 and Aug 29, 2025 — classified as 4 injuries.

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.

• 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 LEFT EYE. A SEPARATE MDR WILL BE SUBMITTED TO ADDRESS THE ISSUES REPORTED WITH THE RIGHT EYE.

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

  MAUDE report 22929493 ↗
• InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH A TECNIS ODYSSEY SIMPLICITY INTRAOCULAR LENS (IOL) EXPERIENCED INTOLERABLE VISION QUALITY IN THE LEFT EYE (OS) DURING A POST-OPERATIVE VISIT. THE LENS WAS SUBSEQUENTLY EXPLANTED. THE PATIENT¿S BEST-CORRECTED VISUAL ACUITY (BSCVA) IMPROVED FROM 20/50 PRE-OPERATIVELY TO 20/40 POST-OPERATIVELY. THERE WERE NO UNPLANNED INCISION ENLARGEMENTS, SUTURES, VITRECTOMY, OR PROCEDURAL DELAYS, AND THE PATIENT DID NOT EXPERIENCE ANY TEMPORARY OR PERMANENT IMPAIRMENTS OR LIMITATIONS IN DAILY ACTIVITIES. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 22868823 ↗
• InjuryFeb 21, 2025Adverse 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 LEFT EYE BECAUSE OF SPECIFIC VISUAL ISSUES. THE PATIENT REPORTED THAT NEAR, INTERMEDIATE, AND NIGHT VISION WERE BLURRY AND FUZZY. A NON-JOHNSON & JOHNSON LENS OF 16.0 DIOPTER WAS USED AS A REPLACEMENT. NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTIONS SUCH AS VITRECTOMY, SUTURES, OR INCISION ENLARGEMENT WAS REQUIRED. THERE WAS NO PATIENT INJURY REPORTED. IT WAS INDICATED THAT THE PATIENT IS DOING BETTER, IMPROVED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 21434846 ↗
• InjuryFeb 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING IMPLANTATION OF THE PRELOADED INTRAOCULAR LENS (IOL) IN THE PATIENT'S RIGHT EYE, THE VISUAL ACUITY DID NOT IMPROVE EVEN ONE WEEK AFTER SURGERY. THE DISTANCE UNAIDED VISUAL ACUITY WAS 0.4 AND THE PATIENT REQUESTED A REPLACEMENT. THE IOL WAS SCHEDULED TO BE REPLACED WITH A MONOFOCAL LENS IN (B)(6) 2025. THROUGH FOLLOW-UP, WE LEARNED THAT THE LENS WAS EXPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21381587 ↗