TECNIS ODYSSEY TORIC II IOL DRT225 (REF DRT2250280)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TEC ODYSSEY TOR II SMPCY 28.0D 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 05050474812109), received between Aug 11, 2026 and Aug 11, 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
- Visual Disturbances1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 11, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient underwent bilateral implantation of preloaded multifocal intraocular lenses (IOLs), models DXW150 and DRT225. Following implantation, the patient experienced intolerance to the multifocal intraocular lenses. As a result, both lenses were explanted during secondary surgical procedures.The replacement lens for the patient's right eye was a different model with the same diopter power, DET300U285 (SN (b)(6)). The replacement lens for the patient's left eye was a different model with a 0.5 diopter difference, DET150U285 (SN (b)(6)). The patient reported difficulty reading medication labels, viewing her phone, and reading expiration dates on food packaging. No incision enlargement, sutures, vitrectomy, or procedure delays were reported. The patient's outcome status was reported as unknown.The patient's preoperative refraction prior to the original surgery was +2.75 -0.75 x 076 in the right eye and +2.25 -0.50 x 040 in the left eye, with a target postoperative refraction of plano in both eyes. The postoperative refraction was reported as +1.00 -1.50 x 100 in the right eye and plano -0.75 x 150 in the left eye. The Directions for Use (DFU) were followed, and
Patient problems: Visual Disturbances
MAUDE report 50203038 ↗
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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