TECNIS ODYSSEY TORIC II IOL DRT300 (REF DRT3000145)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TEC ODYSSEY TOR II SMPCY 14.5D 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
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474812420), received between Jan 31, 2025 and Jun 23, 2025 — classified as 2 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 Problem2
Patient problems
- Corneal Edema1
- Flashers1
- Halo1
- Visual Disturbances1
- Visual Impairment1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE DRT300 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OPERATIVE EYE. POST-OPERATIVELY DUE TO COMPLAINTS OF SEVERE GLARE, HALO, AND STARBURST EFFECTS THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE. INFORMATION REGARDING THE REPLACEMENT IOL AND PATIENT STATUS POST LENS EXCHANGE ARE UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Flashers; Halo; Visual Disturbances
MAUDE report 22312080 ↗InjuryJan 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE ASTIGMATISM OF A PATIENT WORSENED AFTER IMPLANTING PRELOADED INTRAOCULAR LENS (IOL) IN THE LEFT EYE. THE VISUAL ACUITIES BEFORE AND AFTER IMPLANTATION WERE 20/70. IT WAS NOTED THAT THE PATIENT HAD STOPPED PERFORMING DAILY ACTIVITIES DUE TO THE ISSUE AND THAT AN IOL EXCHANGE WAS PLANNED. UPON FOLLOW-UP, IT WAS STATED THAT THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER JNJ LENS. THE PATIENT HAD CORNEAL EDEMA POST-OPERATION AND HAD ONLY BEEN SEEN FOR ONE FOLLOW-UP. THE PATIENT STILL HAD CORNEAL EDEMA, AND A FOLLOW-UP WAS SCHEDULED FOR A WEEK LATER. THE ORIGINAL EXPLANTED LENS IS NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Corneal Edema; Visual Impairment
MAUDE report 21285034 ↗
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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