TECNIS ODYSSEY TORIC II IOL DRT300 (REF DRT3000260)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TEC ODYSSEY TOR II SMPCY 26.0D 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
- 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 05050474812659), received between Feb 21, 2025 and Feb 21, 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
- Visual Impairment1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 21, 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 OCULAR DEXTER (RIGHT EYE). POST-OPERATIVELY, THE PATIENT HAD A REFRACTIVE MISS OF ONE (01) DIOPTER. IT WAS ORIGINALLY THOUGHT THE IOL HAD ROTATED BETWEEN 8-11 DEGREES HOWEVER, IT WAS CONFIRMED TO A FORMULA RELATED ISSUE AND NOT A IOL ROTATIONAL ISSUE. IN A SECONDARY SURGICAL PROCEDURE, THE DRT300 IOL WAS EXPLANTED AND REPLACED WITH A DRT225 27.0 DIOPTER IOL. THERE WAS NO PATIENT HARM AND NO VITRECTOMY DURING THE EXPLANT PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Visual Impairment
MAUDE report 21434952 ↗
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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