TECNIS ODYSSEY TORIC II IOL DRT300 (REF DRT3000135)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TEC ODYSSEY TOR II SMPCY 13.5D 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 05050474812406), received between Jan 28, 2026 and Jan 28, 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
- Blurred Vision1
- 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 28, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY THE PATIENT THAT FOLLOWING THE IMPLANTATION OF A PRELOADED MULTIFOCAL TORIC INTRAOCULAR LENS (IOL) IN THE RIGHT AND LEFT EYE, THE PATIENT EXPERIENCED PERSISTENT HALOS AROUND LIGHTS IN BOTH EYES. THE PHYSICIAN HAD INDICATED THAT THE HALOS WOULD RESOLVE WITHIN A MONTH, THEN SIX MONTHS, AND EVENTUALLY OVER TIME; HOWEVER, THE ISSUE HAS PERSISTED FOR 15 MONTHS WITHOUT IMPROVEMENT. THE PATIENT DESCRIBED SEEING ONE OR TWO CIRCLES OF LIGHT AROUND EVERY LIGHT SOURCE, REGARDLESS OF BRIGHTNESS OR TIME OF DAY, WHICH AFFECTS DAILY ACTIVITIES SUCH AS NIGHT DRIVING AND VIEWING LIGHTED DECORATIONS DURING HOLIDAYS. THE HALOS INTERFERE WITH VISIBILITY OF TURN SIGNALS AND SEEING THE BACKS OF VEHICLES AHEAD WHILE DRIVING AT NIGHT AND ARE DISRUPTIVE DURING DAYTIME ACTIVITIES. THE PATIENT ALSO REPORTED SUBOPTIMAL NEAR AND ARM'S LENGTH VISION, OCCASIONALLY REQUIRING READERS FOR TASKS SUCH AS LAPTOP WORK. THE LENSES REMAIN IMPLANTED, AND NO MEDICAL OR SURGICAL INTERVENTION HAS BEEN PERFORMED OR PLANNED. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS CAPTURING THE EVENT FOR THE LEFT EYE. A SEPARATE REPORT WILL CAPTURE THE EVENT FOR THE RIGHT EYE.
Patient problems: Blurred Vision; Halo; Visual Disturbances
MAUDE report 24206167 ↗
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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