TECNIS ODYSSEY TORIC II IOL DRT150 (REF DRT1500235)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TEC ODYSSEY TOR II SMPCY 23.5D 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
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474811423), received between Jan 9, 2025 and Sep 30, 2026 — classified as 5 injuries.
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 Problem5
Patient problems
- Visual Disturbances4
- Halo2
- Blurred Vision1
- Eye Irritation1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Halo; Visual Disturbances
MAUDE report 50952802 ↗InjuryNov 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A LENS EXCHANGE PROCEDURE DUE TO HALO AND GLARE ISSUES WITH A PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL), MODEL DRT150. THE LENS WAS REPLACED WITH A MONOFOCAL TORIC INTRAOCULAR LENS, MODEL DIU150 OF 23.5 DIOPTER. THIS SECONDARY SURGICAL INTERVENTION WAS CLASSIFIED AS A PATIENT ADVERSE EVENT RELATED TO THE DEVICE. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Halo; Visual Disturbances
MAUDE report 23660337 ↗InjurySep 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PRELOADED MULTIFOCAL TORIC INTRAOCULAR LENS (IOL) WAS REMOVED FROM THE LEFT EYE OF A PATIENT DUE TO DYSPHOTOPSIA. THE PATIENT HAD VISUAL ACUITY (VA) 20/25 AND J1. THE EXPLANTED LENS WAS REPLACED WITH A ZCU MODEL TORIC LENS OF THE SAME POWER. THE PATIENT IS DOING OKAY. NO FURTHER INFORMATION WAS PROVIDED. THIS EMDR REPORT PERTAINS TO PATIENT'S LEFT EYE. A SEPARATE REPORT WILL BE SUBMITTED FOR THE PATIENT'S RIGHT EYE.
Patient problems: Visual Disturbances
MAUDE report 23089481 ↗InjurySep 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PRELOADED MULTIFOCAL TORIC INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE RIGHT EYE OF A PATIENT DUE TO DYSPHOTOPSIA. THE PATIENT HAD VISUAL ACUITY (VA) 20/25 AND J1. THE EXPLANTED LENS WAS REPLACED WITH A ZCU150 TORIC LENS OF THE SAME POWER AS THE ORIGINAL LENS. THERE WERE NO SURGICAL INTERVENTIONS REPORTED. THE PATIENT IS DOING OKAY. NO FURTHER INFORMATION WAS PROVIDED. THIS EMDR REPORT PERTAINS TO PATIENT'S RIGHT EYE. A SEPARATE REPORT WILL BE SUBMITTED FOR THE PATIENT'S LEFT EYE.
Patient problems: Visual Disturbances
MAUDE report 23089476 ↗InjuryJan 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE INTRAOCULAR LENS WAS EXPLANTED DUE TO BLURRY VISION AND IRRITATION. IT WAS REMOVED AND REPLACED WITH ANOTHER JOHNSON & JOHNSON LENS DURING A SECONDARY SURGICAL PROCEDURE. INCISION ENLARGEMENT WAS REQUIRED. NO INJURY OR ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Blurred Vision; Eye Irritation
MAUDE report 21120610 ↗
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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