TECNIS ODYSSEY TORIC II IOL DRT375 (REF DRT3750235)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TEC ODYSSEY TOR II SMPCY 23.5D CYL3.75 · Class 3 · Implant
All models of TECNIS ODYSSEY TORIC II IOL (106)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474813199), received between Aug 14, 2025 and Aug 14, 2025 — classified as 2 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Blurred Vision2
- Halo2
- Visual Disturbances2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT WHO IS EXPERIENCING BLURRY VISION, HALOS AND GLARES AT NIGHT IS SCHEDULED FOR THE EXPLANTATION OF MULTIFOCAL PRELOADED TORIC INTRAOCULAR LENSES (IOLS). ALTHOUGH IT HAS BEEN INDICATED THAT THE PATIENT IS NOT DEBILITATED, THE PATIENT EXPLICITLY REPORTED THAT THEY CANNOT DRIVE AT NIGHT, THOUGH THIS HAS NOT BEEN MEDICALLY TESTED. THE SYMPTOMS ARE PRESENT IN BOTH EYES, AND THE PATIENT HAS NO PRE-EXISTING CONDITIONS CONTRIBUTING TO THESE ISSUES. NO SPECIFIC REPLACEMENT LENS MODEL OR DIOPTER HAS BEEN INDICATED. NO FURTHER INFORMATION WAS PROVIDED. THIS EMDR PERTAINS TO THE PATIENT'S LEFT EYE. A SEPARATE REPORT WILL BE SUBMITTED FOR THE RIGHT EYE.
Patient problems: Blurred Vision; Halo; Visual Disturbances
MAUDE report 22811448 ↗InjuryAug 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT WHO IS EXPERIENCING BLURRY VISION, HALOS AND GLARES AT NIGHT IS SCHEDULED FOR THE EXPLANTATION OF MULTIFOCAL PRELOADED TORIC INTRAOCULAR LENSES (IOLS). ALTHOUGH IT HAS BEEN INDICATED THAT THE PATIENT IS NOT DEBILITATED, THE PATIENT EXPLICITLY REPORTED THAT THEY CANNOT DRIVE AT NIGHT, THOUGH THIS HAS NOT BEEN MEDICALLY TESTED. THE SYMPTOMS ARE PRESENT IN BOTH EYES, AND THE PATIENT HAS NO PRE-EXISTING CONDITIONS CONTRIBUTING TO THESE ISSUES. NO SPECIFIC REPLACEMENT LENS MODEL OR DIOPTER HAS BEEN INDICATED. NO FURTHER INFORMATION WAS PROVIDED. THIS EMDR PERTAINS TO THE PATIENT'S RIGHT EYE. A SEPARATE REPORT WILL BE SUBMITTED FOR THE LEFT EYE.
Patient problems: Blurred Vision; Halo; Visual Disturbances
MAUDE report 22811395 ↗
Other Lens, multifocal intraocular devices
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular144 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular1 recall66 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular113 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular112 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular110 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular107 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular104 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular93 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page