TECNIS ODYSSEY TORIC II IOL DRT375 (REF DRT3750165)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TEC ODYSSEY TOR II SMPCY 16.5D 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 05050474813052), received between Mar 24, 2025 and Jul 1, 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
- Discomfort1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PRELOADED LENS WAS EXPLANTED BECAUSE THE VISUAL OUTCOMES DID NOT MEET STANDARD EXPECTATIONS, AND THE PATIENT WAS UNHAPPY. IT WAS REMOVED AND REPLACED DURING A SECONDARY SURGICAL PROCEDURE WITH AN UNKNOWN INTRAOCULAR LENS. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Blurred Vision; Discomfort
MAUDE report 22379110 ↗InjuryMar 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE NON PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED AS THE PATIENT REPORTEDLY EXPERIENCED FUZZY VISION POST-OPERATIVELY, WITH VISION UNABLE TO IMPROVE BEYOND 20/40 WITH REFRACTION. THE LENS WAS SUBSEQUENTLY EXPLANTED, THE PATIENT WAS REPORTED TO BE PERMANENTLY IMPAIRED, AND THEIR DAILY ACTIVITIES WERE SIGNIFICANTLY AFFECTED. THE PATIENT DID NOT SEEK FURTHER MEDICAL ATTENTION, BUT MEDICATION WAS PRESCRIBED FOLLOWING THE INCIDENT. FROM ADDITIONAL INFORMATION IT WAS LEARNT THAT LENS HAD CONTRIBUTED TO FUZZY VISION. THERE WAS NO PATIENT ISSUE. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AND REPLACED WITH LENS FROM ANOTHER MANUFACTURER. THE PATIENT FEELS BETTER AND IMPROVED IN VISION WITH THE REPLACED LENS. THERE WAS NO USE ERROR. THERE WERE DEBILITATING CONDITIONS IN PATIENT. THE SYMPTOMS SIGNIFICANTLY INTERFERE WITH ONE OR MORE DAILY ACTIVITIES WITH THE PATIENT. NO OTHER INFORMATION IS AVAILABLE.
Patient problems: Blurred Vision
MAUDE report 21684770 ↗
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.
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