TECNIS ODYSSEY TORIC II IOL DRT150 (REF DRT1500265)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TEC ODYSSEY TOR II SMPCY 26.5D 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
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474811485), received between Jan 6, 2025 and Dec 8, 2025 — classified as 1 injury, 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
- Adverse Event Without Identified Device or Use Problem1
- Device Difficult to Setup or Prepare1
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S LEFT EYE. HOWEVER, THE PATIENT WAS UNABLE TO READ AND HAD DIFFICULTY WITH DISTANCE VISION. WHEN THE EVENT WAS INITIALLY REPORTED THE DOCTOR PLANNED ON EXPLANTING THE IOL AND REPLACING IT WITH A DIFFERENT MANUFACTURER¿S LENS MODEL RXSIGHT LAL (LIGHT ADJUSTABLE LENS). WHEN THE JOHNSON AND JOHNSON INVESTIGATION WAS COMPLETED IT WAS NOTED THAT THE LENS WAS RETURNED, WHICH INDICATES IT WAS EXPLANTED. JNJ PERFORMED FOLLOW-UP TO GET MORE DETAILS REGARDING THE EXPLANT DATE AND REPLACEMENT IOL BUT THE INFORMATION WAS NOT PROVIDED. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23739244 ↗MalfunctionJan 6, 2025Device Difficult to Setup or Prepare; Scratched Material; Device Difficult to Setup or Prepare; Scratched Material
IT WAS REPORTED THAT DURING THE IMPLANTATION OF A TORIC INTRAOCULAR LENS (IOL), THE DOCTOR FELT THAT IT WAS A LITTLE TIGHT GOING IN BUT COMPLETED THE IMPLANT. THE DOCTOR THEN MADE THE DECISION TO EXTRACT THE IMPLANT AND REPLACE IT WITH ANOTHER ODYSSEY LENS. THERE WERE NO ISSUES WITH THE SECOND IMPLANT. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21088357 ↗
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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