TECNIS ODYSSEY TORIC II IOL DRT225 (REF DRT2250265)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TEC ODYSSEY TOR II SMPCY 26.5D CYL2.25 · 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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05050474812079), received between Nov 14, 2025 and Nov 14, 2025 — classified as 1 injury.
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 Problem1
Patient problems
- Conjunctivitis1
- Corneal Clouding/Hazing1
- Eye Irritation1
- Eye Pain1
- Ptosis1
- Visual Disturbances1
- Visual Impairment1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AFTER THE PRELOADED MULTIFOCAL TORIC INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE LEFT EYE, THE PATIENT EXPERIENCED GENERAL DISCOMFORT, FLICKERS IN VISION, AND ITCHING, IN ADDITION TO CONDITIONS OF PRESBYOPIA, CONJUNCTIVITIS, OPACITY, REFRACTIVE HYPEROPIA, ASTIGMATISM, AND PTOSIS OF THE EYELID. THE PATIENT WAS INITIALLY SCHEDULED TO HAVE A SPECIFIC NON-JOHNSON AND JOHNSON IOL IMPLANTED; HOWEVER, DUE TO A RECALL OF THE OTHER LENS, THE JOHNSON AND JOHNSON LENS WAS IMPLANTED INSTEAD, WHICH WAS NOT A PROPER MATCH FOR THE OTHER EYE. THE SYMPTOMS SIGNIFICANTLY INTERFERE WITH THE PATIENT'S DAILY ACTIVITIES. THE PATIENT REPORTED THAT THERE ARE NO ISSUES WITH VISUAL ACUITY. AN EXPLANT PROCEDURE WAS ORIGINALLY SCHEDULED FOR ON (B)(6) 2025 BUT WAS CANCELED DUE TO THE REQUIREMENT FOR CARDIAC CLEARANCE. THE EXPLANT PROCEDURE REMAINS PENDING DUE TO HEALTH ISSUES OF THE PATIENT, AND THE PATIENT CONTINUES TO EXPERIENCE THE AFOREMENTIONED SYMPTOMS. THE LENS REMAINS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Conjunctivitis; Corneal Clouding/Hazing; Eye Irritation; Eye Pain; Ptosis; Visual Disturbances; Visual Impairment
MAUDE report 23555495 ↗
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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