TECNIS ODYSSEY TORIC II IOL DRT375 (REF DRT3750160)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TEC ODYSSEY TOR II SMPCY 16.0D 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 05050474813045), received between Jul 21, 2025 and Aug 10, 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 Vision1
- Halo1
- Visual Impairment1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A TECNIS ODYSSEY SIMPLICITY INTRAOCULAR LENS (IOL) 16.0D ON (B)(6) 2025, EXPERIENCED UNCLEAR OVERALL VISION, WORSENED NEAR VISION, AND HALOS AROUND LIGHTS AT NIGHT. THE DIRECTIONS FOR USE WERE FOLLOWED. THE ISSUE WAS IDENTIFIED DURING A POST-OPERATIVE EXAMINATION, AND THE LENS WAS EXPLANTED DURING A SECONDARY SURGERY ON JULY 15, 2025. THERE WERE NO UNPLANNED SURGICAL COMPLICATIONS, AND THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Blurred Vision; Halo
MAUDE report 22768172 ↗InjuryJul 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE LENS WAS EXPLANTED DUE TO VISUAL OUTCOMES THAT DID NOT MEET THE EXPECTED STANDARDS, LEADING TO PATIENT DISSATISFACTION. THE LENS WAS EXPLANTED DURING A SECONDARY SURGICAL PROCEDURE WITH AN UNKNOWN INTRAOCULAR LENS. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Visual Impairment
MAUDE report 22561496 ↗
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