TECNIS ODYSSEY TORIC II IOL DRT150 (REF DRT1500150)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TEC ODYSSEY TOR II SMPCY 15.0D CYL1.50 · 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
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474811256), received between Apr 30, 2025 and Feb 13, 2026 — classified as 3 injuries.
The most frequently reported specific device problem is “Application Program Problem: Dose Calculation Error” (2 reports).
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
- Application Program Problem: Dose Calculation Error2
- Adverse Event Without Identified Device or Use Problem1
- Incorrect, Inadequate or Imprecise Result or Readings1
Patient problems
- Capsular Bag Tear1
- No Clinical Signs, Symptoms or Conditions1
- Visual Impairment1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryFeb 13, 2026Application Program Problem: Dose Calculation Error
THE DRT150 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S EYE. POST-OPERATIVELY, THE SURGEON SELECTED THE WRONG IOL, THUS THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A DRN00V 16.0 IOL. PATIENT IS HEALTHY AND WELL, THERE NO PROBLEMS WITH THE IOL, AND SURGEON IS PLEASED WITH OUTCOME. PATIENT IS SEEING WELL WITH THE NEW, BETTER IOL SELECTION. THE SUSPECT IOL IS NOT AVAILABLE FOR INVESTIGATION AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24340061 ↗InjuryMay 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS INSERTED INTO THE PATIENT¿S EYE AND THEN REMOVED BECAUSE THE CAPSULAR BAG BROKE. THE SURGEON HAD TO CUT THE IOL OUT OF THE EYE. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Capsular Bag Tear
MAUDE report 22092929 ↗InjuryApr 30, 2025Application Program Problem: Dose Calculation Error; Incorrect, Inadequate or Imprecise Result or Readings; Application Program Problem: Dose Calculation Error; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S EYE DUE TO HYPEROPIC SURPRISE-POWER MISS. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THERE WAS PATIENT INJURY. THERE WAS NO MEDICAL/SURGICAL INTERVENTION REQUIRED. THE PATIENT IS DOING FINE. FROM ADDITIONAL INFORMATION IT WAS LEARNT THAT LENS REPLACED DUE TO CALCULATION ISSUE RESULTING IN A HYPEROPIC OUTCOME. THE DAILY ACTIVITIES WERE NOT AFFECTED. THE PATIENT WAS SATISFIED WITH THE REPLACED LENS. NO OTHER INFORMATION IS AVAILABLE.
Patient problems: Visual Impairment
MAUDE report 21939660 ↗
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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