TECNIS ODYSSEY TORIC II IOL DRT375 (REF DRT3750190)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TEC ODYSSEY TOR II SMPCY 19.0D 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
- 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 05050474813106), received between Jul 14, 2025 and Jul 14, 2025 — 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
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS INITIALLY REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE ON (B)(6) 2025. FOUR DAYS AFTER SURGERY, THE PATIENT'S DISTANCE VISION WAS 0.6P (1.2×S+1.00D C-1. 00DA75) AND NEAR VISION WAS 0.4. THE PATIENT IS VERY SATISFIED WITH BOTH DISTANCE AND MIDDLE VISION, BUT SOMEWHAT DISSATISFIED WITH NEAR VISION. A REPLACEMENT IS BEING CONSIDERED, DEPENDING ON FUTURE TEST RESULTS. NO PATIENT INJURY WAS REPORTED, AND NO OTHER MEDICAL INTERVENTION WAS REQUIRED. THROUGH FOLLOW-UP, WE LEARNED THAT A LENS EXPLANT WAS ATTEMPTED; HOWEVER, THE LENS WAS LEFT IMPLANTED BECAUSE ADHESION BETWEEN THE HAPTICS AND THE POSTERIOR CAPSULE HAD BEGUN, AND THE ZONULE WAS NOTABLY WEAK. THE ACCOUNT INDICATED THAT IF THE LENS REPLACEMENT PROCEDURE CONTINUED ANY LONGER, THERE WAS A RISK OF THE IOL DISLODGING. CONSEQUENTLY, THE HAPTIC THAT HAD BEEN REMOVED FROM ONE SIDE WAS RETURNED TO THE BAG, RESULTING IN THE DISCONTINUATION OF THE REPLACEMENT OPERATION. AFTER THE PROCEDURE, THE PATIENT WAS PRESCRIBED WITH DIQUAS, AN OPHTHALMIC SOLUTION TO TREAT DRY EYES AND AFTER SOME DAYS, THE PATIENT SEEMED TO BE ABLE TO READ SMALL LETTERS. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Blurred Vision
MAUDE report 22503336 ↗
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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