TECNIS ODYSSEY TORIC II IOL DRT300 (REF DRT3000210)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TEC ODYSSEY TOR II SMPCY 21.0D 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
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474812550), received between Mar 12, 2026 and May 29, 2026 — classified as 3 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 Problem3
Patient problems
- Halo2
- Eye Injury1
- Visual Disturbances1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMay 29, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A SINGLE PIECE PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE DUE TO UNSPECIFIED REASONS. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Eye Injury
MAUDE report 25333606 ↗InjuryMay 18, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT EXPERIENCED INTOLERABLE HALO AND GLARE SYMPTOMS FOLLOWING IMPLANTATION OF A SINGLE-PIECE PRELOADED MULTIFOCAL INTRAOCULAR LENS IN THE RIGHT EYE, AND THE ORIGINAL LENS WAS EXPLANTED DURING A SECONDARY SURGERY ON THE SAME DATE THE EVENT OCCURRED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Halo; Visual Disturbances
MAUDE report 25209146 ↗InjuryMar 12, 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 LEFT EYE. THE PATIENT WAS UNABLE TO ADJUST TO THE HALOS. THERE WERE NO COMPLICATIONS SUCH AS A CAPSULE TEAR, VITRECTOMY OR SUTURES. THE IOL WAS EXPLANTED AND REPLACED WITH A NON-JOHNSON AND JOHNSON LENS. THE PATIENT OUTCOME WAS REPORTED AS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Halo
MAUDE report 24586544 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page