TECNIS ODYSSEY TORIC II IOL DRT225 (REF DRT2250230)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TEC ODYSSEY TOR II SMPCY 23.0D CYL2.25 · 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 05050474812000), received between Jan 22, 2026 and Jan 22, 2026 — 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
- Halo1
- Visual Disturbances1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 22, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S BOTH LEFT AND RIGHT EYE. THIS REPORT CAPTURES THE LEFT EYE. THE PATIENT EXPERIENCED SEVERE GLARE AND HALOS. THE PATIENT COULD NOT DRIVE OR EVEN LEAVE HER HOME AND WAS DEPRESSED. THE SYMPTOMS PERSISTED WHILE THE LENS WAS IN THE EYE. REPORTEDLY, THE DIRECTIONS FOR USE WERE FOLLOWED. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, SUTURES, DELAY IN PROCEDURE, OR MEDICATION OUTSIDE THE STANDARD OF CARE. THE PATIENT¿S PRE-OPERATIVE BEST CORRECTED VISUAL ACUITY (BSCVA) WAS 20/20 AND POST BSCVA WAS 20/80. CONSEQUENTLY, THE IOL WAS REMOVED AND REPLACED WITH A DIFFERENT TYPE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR THE LEFT EYE. MANUFACTURER REPORT NUMBER. THE RIGHT EYE IS BEING REPORTED IN MANUFACTURER REPORT NUMBER 3012236936-2026-0000220.
Patient problems: Halo; Visual Disturbances
MAUDE report 24157703 ↗
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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