TECNIS ODYSSEY TORIC II IOL DRT375 (REF DRT3750150)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TEC ODYSSEY TOR II SMPCY 15.0D CYL3.75 · 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474813021), received between Oct 1, 2024 and Jul 31, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
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
- Break1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Visual Disturbances1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 31, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a preloaded multifocal toric intraocular lens (IOL) implanted in the patient's eye was subsequently explanted due to glare. No further information was provided.
Patient problems: Visual Disturbances
MAUDE report 50100401 ↗MalfunctionOct 1, 2024Break; Break
DEFECTIVE HAZY LENS WAS REPORTED BY THE PHYSICIAN FOLLOWING COMPLETE INSERTION OF THE PRE-LOADED DRT375 MODEL INTRAOCULAR LENS (IOL). THE IOL WAS REMOVED DURING THE SAME PROCEDURE AND REPLACED WITH A BACK-UP DRT375 15.0 DIOPTER IOL THAT WAS WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE). DURING THE PROCEDURE, THERE WAS NO SERIOUS PATIENT INJURY, SUTURES, NOR VITRECTOMY HOWEVER, THE INCISION WAS ENLARGED. PATIENT PROGNOSIS POST-PROCEDURE WAS REPORTED AS POST-OP DAY 1 HEALING WITHIN NORMAL LIMITS (WNL). THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 20346249 ↗
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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