TECNIS ODYSSEY TORIC II IOL DRT375 (REF DRT3750170)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TEC ODYSSEY TOR II SMPCY 17.0D CYL3.75 · 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 05050474813069), received between Dec 12, 2025 and Dec 12, 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 Impairment1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 12, 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 RIGHT EYE, THE PATIENT STILL NEEDED TO USE READING GLASSES FOR COMPUTER WORK, READING, AND PHONE USE. THE ISSUE WAS FIRST IDENTIFIED DURING A POST-OPERATIVE EXAMINATION. THE PATIENT'S PRE-OPERATIVE (PRE-OP) REFRACTION WAS 20/50-1 AND PRE-OP BEST SPECTACLE CORRECTED VISUAL ACUITY (BSCVA) WAS 20/25-2. THE PATIENT'S POST-OPERATIVE (POST-OP) REFRACTION FOR THE ORIGINAL LENS WAS 20/25-1 AND POST-OP BSCVA FOR THE ORIGINAL LENS WAS 20/25. THE INTENDED TARGET REFRACTION WAS +0.05. THE PATIENT DID NOT HAVE A LOSS OF 2 OR MORE LINES OF BSCVA. THE PATIENT WAS OVER CORRECTED. THE PATIENT DID NOT HAVE ANY PRE-EXISTING CONDITION THAT AFFECTED CALCULATION. THE LENS WAS SUBSEQUENTLY EXPLANTED DURING A SECONDARY SURGERY AND REPLACED WITH A NON-JOHNSON AND JOHNSON IOL (+17.5 DIOPTER). THERE WAS NO DELAY IN PROCEDURE. THE PROCEDURE DID NOT INVOLVE UNPLANNED INCISION ENLARGEMENT, SUTURES, OR VITRECTOMY. NO ADDITIONAL MEDICAL ATTENTION WAS NEEDED AND NO MEDICATION WAS PRESCRIBED THAT WAS OUTSIDE THE STANDARD OF CARE. THERE WAS NO PATIENT INJURY. THE PATIENT HAS FULLY RECOVERED. THE PATIENT'S POST-OPERA
Patient problems: Visual Impairment
MAUDE report 23794857 ↗
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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