TECNIS ODYSSEY TORIC II IOL DRT225 (REF DRT2250170)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TEC ODYSSEY TOR II SMPCY 17.0D 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
- 4
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474811881), received between Apr 28, 2025 and May 8, 2026 — classified as 3 injuries, 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 Problem2
- Break1
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Eye Injury1
- Visual Disturbances1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 8, 2026Scratched Material
CUSTOMER REPORTED THAT DURING A PROCEDURE, A LENS WITH SERIAL NUMBER (B)(6) AND MODEL DRT225 17.0 WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD). THE PATIENT WAS REPORTED TO BE STABLE FOLLOWING THE PROCEDURE. A MARK WAS IDENTIFIED ON THE IMPLANTED LENS, NECESSITATING ITS REMOVAL. THE INCISION WAS ENLARGED DURING THE PROCEDURE, BUT SUTURES WERE NOT UTILIZED. A BACKUP LENS WITH SERIAL NUMBER (B)(6) AND THE SAME MODEL, DRT225 17.0, WAS SUCCESSFULLY IMPLANTED, AND THE ORIGINAL LENS WAS DISCARDED. NO HARM OR ADVERSE EVENTS WERE REPORTED FOR THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25128032 ↗InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PRELOADED MULTIFOCAL TORIC INTRAOCULAR LENS (IOL) WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE DUE TO THE PATIENT BEING UNABLE TO ADAPT TO THE LENS AND UNABLE TO DRIVE. ANOTHER JOHNSON AND JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (EYHANCE). THE PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Visual Disturbances
MAUDE report 23822609 ↗InjuryNov 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE DRT225 MODEL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S EYE DURING A SECONDARY SURGICAL PROCEDURE FOR UNKNOWN REASONS. THE FOLLOWING ARE ALSO ALL UNKNOWNS: REPLACEMENT IOL INFORMATION AND PATIENT PROGNOSIS POST LENS EXPLANT. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Eye Injury
MAUDE report 23627973 ↗InjuryApr 28, 2025Break; Break
IT WAS REPORTED THAT A PRELOADED INTRAOCULAR LENS (IOL) WAS DEFECTIVE, WHICH WAS NOTICED DURING THE POST-OPERATIVE EXAMINATION. THE PATIENT'S DAILY ACTIVITIES WERE SIGNIFICANTLY DISTURBED. THE LENS WAS EXPLANTED AND REPLACED WITH AN UNKNOWN IOL. NO FURTHER INFORMATION WAS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21922809 ↗
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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