TECNIS ODYSSEY TORIC II IOL DRT150 (REF DRT1500250)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TEC ODYSSEY TOR II SMPCY 25.0D CYL1.50 · 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
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474811454), received between Oct 16, 2025 and Jan 27, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Material Discolored” (1 report).
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
- Material Discolored1
Patient problems
- Blurred Vision2
- Visual Impairment1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 27, 2026Material Discolored
IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S EYE. THE PATIENT REPORTED THAT THE LENS WAS NOT CLEAR. THE SURGEON RE-EVALUATED THE MEASUREMENTS AND SELECTED A DIFFERENT DIOPTER FOR THE REPLACEMENT LENS. THE IOL WAS EXPLANTED AND REPLACED. THE CUSTOMER COMMENTED THAT THERE WERE NO ISSUES WITH THE LENS. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Blurred Vision
MAUDE report 24196589 ↗InjuryOct 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS DISSATISFIED FOLLOWING THE PRELOADED TORIC INTRAOCULAR LENSES (IOL) IMPLANTATION. THE PATIENT EXPERIENCED WAXY VISION IN BOTH EYES AND REQUESTED A LENS EXCHANGE. HOWEVER, THE IOLS REMAIN IMPLANTED. FURTHER FOLLOW UP REVEALED THAT THE PATIENT REPORTS SEEING A WHITISH OR BLURRY APPEARANCE, CONSISTENT WITH WAXY VISION SYMPTOMS AND THE ONSET DATE WAS (B)(6) 2025. THE CORRECTED VISUAL ACUITY HAS GRADUALLY DECREASED OVER TIME IN BOTH EYES. THE PATIENT UNDERWENT A FOLLOW-UP EXAMINATION AND THE UNCORRECTED RIGHT DISTANCE VISION WAS 0.8 AND THE CORRECTED LEFT DISTANCE VISION WAS 0.4 (CORRECTED TO 0.8 WITH S -1.0D). NO FURTHER INFORMATION WAS PROVIDED. A SEPARATE REPORT WILL BE SUBMITTED FOR EACH IOL, THIS REPORT IS RELATED TO THE LENS IMPLANTED IN THE PATIENT'S RIGHT EYE.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 23319401 ↗
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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