TECNIS ODYSSEY TORIC II IOL DRT300 (REF DRT3000310)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TEC ODYSSEY TOR II SMPCY 31.0D CYL3.00 · 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 05050474812758), received between Oct 24, 2025 and Oct 24, 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
- Visual Disturbances1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 24, 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, THE PATIENT REQUIRED AN EXPLANT DUE TO DIFFICULTY ADAPTING TO THE MULTIFOCAL LENS WITH THE AMBLYOPIC RIGHT EYE. ANOTHER JOHNSON AND JOHNSON IOL WITH A DIFFERENT MODEL BUT SAME DIOPTER (ZCU300, +31.0) WAS IMPLANTED AS REPLACEMENT. NO UNPLANNED SURGICAL INTERVENTIONS, SUCH AS VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES, WERE NECESSARY, AND NO MEDICATIONS BEYOND THE STANDARD OF CARE WERE PRESCRIBED. THERE ARE NO PLANNED SURGICAL INTERVENTIONS. THE PATIENT DID WELL WITH THE LENS EXCHANGE AND HAS EXPERIENCED A NORMAL POST-OPERATIVE COURSE FOLLOWING SURGERY. THE PRE-OPERATIVE REFRACTION WAS RECORDED AS +7.75-2.00X114, AND THE PRE-OPERATIVE BEST SPECTACLE CORRECTED VISUAL ACUITY (BSCVA) WAS DIFFICULT TO ASCERTAIN DUE TO AMBLYOPIA. POST-OPERATIVE REFRACTION WAS PL-0.25X020, WITH A POST-OPERATIVE BSCVA OF 20/40. THE INTENDED TARGET REFRACTION WAS PLANO SPHERE. THE PATIENT DID NOT EXPERIENCE OVER-CORRECTION OR UNDER-CORRECTION. IT WAS NOTED THAT IT WAS DIFFICULT TO ASCERTAIN IF THERE WAS A LOSS OF TWO OR MORE LINES OF BSCVA DUE TO AMBLYOPIA. THE PATIENT DID NOT HAVE ANY PRE-EXISTING CONDITIONS TH
Patient problems: Visual Disturbances
MAUDE report 23386198 ↗
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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