TECNIS ODYSSEY TORIC II IOL DRT225 (REF DRT2250160)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TEC ODYSSEY TOR II SMPCY 16.0D CYL2.25 · 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05050474811867), received between Mar 10, 2026 and Mar 10, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (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
- Device Difficult to Setup or Prepare1
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 10, 2026Device Difficult to Setup or Prepare; Scratched Material
IT WAS REPORTED THAT DURING IMPLANTATION OF A SINGLE PIECE PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) INTO THE PATIENT'S RIGHT EYE, A RESISTANCE WAS FELT. THE DOCTOR CONTINUED TO INSERT AND OBSERVED A SCRATCH ON THE LEFT SIDE OF THE IOL. THE IOL WAS FULLY INSERTED HOWEVER, IT WAS SUBSEQUENTLY REMOVED AND REPLACED WITH A BACKUP IOL OF THE SAME MODEL AND DIOPTER DURING THE SAME PROCEDURE. DAILY ACTIVITIES WERE NOT AFFECTED AND NO UNPLANNED SURGICAL INTERVENTIONS SUCH AS, INCISION ENLARGEMENT, SUTURES, OR VITRECTOMY WERE REQUIRED. NO MEDICATION PRESCRIBED THAT WAS OUTSIDE OF THE STANDARD OF CARE. BUT THERE WAS A NOTED SURGICAL DELAY OF APPROXIMATELY 10 MINUTES. DIRECTIONS FOR USE WAS FOLLOWED. THE PATIENT HAS FULLY RECOVERED. THE DEVICE WAS DISCARDED BUT A PHOTO WAS TAKEN. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24555064 ↗
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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