TECNIS ODYSSEY TORIC II IOL DRT150 (REF DRT1500165)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TEC ODYSSEY TOR II SMPCY 16.5D 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
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474811287), received between Jan 9, 2025 and Sep 28, 2026 — classified as 4 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 Problem4
Patient problems
- Blurred Vision1
- Eye Injury1
- Halo1
- Visual Disturbances1
- Visual Impairment1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Eye Injury
MAUDE report 50926579 ↗InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S EYE. THE PATIENT EXPERIENCED INTOLERABLE GLARE AND HALOS. CONSEQUENTLY, THE IOL WAS EXPLANTED. JOHNSON AND JOHNSON PERFORMED FOLLOW-UP BUT NO FURTHER DETAILS WERE PROVIDED.
Patient problems: Halo; Visual Disturbances
MAUDE report 24229099 ↗InjuryMay 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S RIGHT EYE DUE UNDILATED REFRACTION LEADING TO RESIDUAL ASTIGMATISM. THE LENS WAS EXPLANTED AND REPLACED WITH A DRN00V LENS IN A SECONDARY PROCEDURE. NO OTHER INFORMATION IS AVAILABLE.
Patient problems: Visual Impairment
MAUDE report 21946066 ↗InjuryJan 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A TORIC INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE DUE TO BLURRY VISION. A NON-JOHNSON & JOHNSON LENS WAS USED AS A REPLACEMENT LENS. THERE WAS AN INCISION ENLARGEMENT, BUT NO OTHER SURGICAL OR MEDICAL INTERVENTIONS REPORTED. NO PATIENT INJURY REPORTED. THE PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Blurred Vision
MAUDE report 21120835 ↗
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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