TECNIS ODYSSEY TORIC II IOL DRT300 (REF DRT3000050)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TEC ODYSSEY TOR II SMPCY 05.0D 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 05050474812239), received between Jun 27, 2025 and Jun 27, 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
- Blurred Vision1
- Visual Disturbances1
- Visual Impairment1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PRELOADED ODYSSEY IOL (INTRAOCULAR LENS) WAS EXPLANTED DUE TO VISION ISSUES. THE PATIENT'S VISUAL ACUITY WITH THE ODYSSEY IOL WAS 20/25; HOWEVER, THE PATIENT REPORTED DISSATISFACTION WITH BOTH NEAR AND DISTANCE VISION QUALITY. CONSEQUENTLY, THE LENS WAS REMOVED AND REPLACED DURING A SECONDARY SURGICAL PROCEDURE WITH A IOL MODEL ZCU. ADDITIONAL INFORMATION REVEALED THAT THE PATIENT'S CONTRAST SENSITIVITY AND CLARITY WERE NEGATIVELY AFFECTED. THE PATIENT EXPRESSED CONCERNS REGARDING BOTH NEAR AND DISTANCE VISION, STATING THAT DEPTH PERCEPTION FELT OFF EVEN WHEN WEARING A CONTACT LENS IN THE LEFT EYE (OS). THE PATIENT ALSO REPORTED EXPERIENCING DOUBLE VISION OR SHADOW IMAGES, PARTICULARLY WHEN FOCUSING ON NEAR OBJECTS. ONE WEEK POST-OPERATION, THE VISUAL ACUITY IN THE RIGHT EYE WAS 20/40-1 (PH 20/30-1, NSC 20/20). NO INJURY OR FURTHER INTERVENTION WAS REQUIRED.
Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment
MAUDE report 22350109 ↗
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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