TECNIS ODYSSEY TORIC II IOL DRT150 (REF DRT1500055)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TEC ODYSSEY TOR II SMPCY 05.5D 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
- 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 05050474811065), received between Jul 8, 2025 and Jul 8, 2025 — classified as 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
- Break1
- Device Difficult to Setup or Prepare1
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.
MalfunctionJul 8, 2025Break; Device Difficult to Setup or Prepare; Break; Device Difficult to Setup or Prepare
IT WAS REPORTED THAT WHEN THE PHYSICIAN USED THE PRELOADED TORIC INTRAOCULAR LENS (IOL) WHICH WAS SET UP BY THE ASSISTANT AS USUAL, THE PHYSICIAN FELT RESISTANCE WHEN TURNING THE PLUNGER. SINCE THERE WAS NO REPLACEMENT DEVICE, THE IOL WAS IMPLANTED. AFTER CLEANING THE IOL DURING IRRIGATION AND ASPIRATION, IT WAS NOTICED THAT THE OPTIC WAS DAMAGED. ACCOUNT INDICATED THAT THE IOL WAS SET WITH BALANCED SALT SOLUTION (BSS) AND THE ASSISTANT EXECUTED THE SET UP UNTIL THE PLUNGER WAS FIRST TURNED. ONE WEEK AFTER SURGERY, THE PATIENT DID NOT HAVE ANY PARTICULAR PROBLEMS OR DISSATISFACTION, SO THE IOL WAS NOT REPLACED. NO PATIENT INJURY WAS REPORTED. NO OTHER MEDICAL INTERVENTION WAS REQUIRED. THROUGH FOLLOW-UP, WE LEARNED THAT THE BSS USED WAS FROM A COMPETITOR AND IT WAS USED AT ROOM TEMPERATURE. THE INSTRUCTIONS FOR USE WERE FOLLOWED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22448611 ↗
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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