TECNIS ODYSSEY TORIC II IOL DRT225 (REF DRT2250175)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TEC ODYSSEY TOR II SMPCY 17.5D 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 05050474811898), received between Jul 31, 2026 and Jul 31, 2026 — 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
- Halo1
- Visual Disturbances1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 31, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient implanted bilaterally with multifocal Toric intraocular lenses (IOLs) experienced poor quality of vision, intolerable halos, and glare following implantation and was unable to drive at night. Visual symptoms were first identified during post-operative examinations. Pre-operative BSCVA was reported as 20/25 in the right eye and 20/20 in the left eye, while post-operative BSCVA was 20/20 in both eyes. Due to difficulty adapting to the lenses, the lenses in both eyes were explanted. The replacement lenses were non-Johnson & Johnson lenses with a power of 17.0 diopters. No capsule tear occurred, and no unplanned medical or surgical interventions, including vitrectomy, incision enlargement, sutures, or medications outside the standard of care, were required. No pre-existing conditions were reported. The patient outcome was reported as doing well following surgery; however, the patient still requires lens adjustment with Praxis. The customer indicated that the directions for use were followed. No further information was provided.This report pertains to the patient's left eye. A separate report is being submitted to document the event associated with the pat
Patient problems: Halo; Visual Disturbances
MAUDE report 50105623 ↗
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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