TECNIS ODYSSEY TORIC II IOL DRT225 (REF DRT2250225)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TEC ODYSSEY TOR II SMPCY 22.5D 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
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474811997), received between Aug 22, 2024 and Nov 23, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Unstable” (1 report).
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
- Unstable1
Patient problems
- Eye Injury1
- Visual Impairment1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE DRT225 MODEL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S EYE DURING A SECONDARY SURGICAL PROCEDURE FOR UNKNOWN REASONS. THE FOLLOWING ARE ALSO ALL UNKNOWNS: REPLACEMENT IOL INFORMATION AND PATIENT PROGNOSIS POST LENS EXPLANT. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Eye Injury
MAUDE report 23627934 ↗MalfunctionAug 22, 2024Unstable; Unstable
IT WAS REPORTED THAT THE AUTOREFRACTOR REPORTING PATIENT TO HAVE 2.25D (DIOPTER) OF RESIDUAL CYLINDER- WAITING ON MANIFEST REFRACTION, 12 DEGREES OFF FROM TARGET TORIC AXIS. THE ISSUE WAS NOTED DURING THE POST OPERATIVE EXAMINATION. IT IS UNKNOWN IF THERE WERE ANY MEDICAL OR SURGICAL INTERVENTIONS. NO DELAY IN PROCEDURE REPORTED. THE LENS REMAINS IMPLANTED. THE PATIENT OUTCOME STATUS IS UNKNOWN AND IT IS UNKNOWN IF THE SYMPTOMS SIGNIFICANTLY INTERFERED WITH PATIENT'S DAILY ACTIVITY. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Visual Impairment
MAUDE report 20044596 ↗
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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