TECNIS ODYSSEY TORIC II IOL DRT300 (REF DRT3000070)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TEC ODYSSEY TOR II SMPCY 07.0D CYL3.00 · 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 05050474812277), received between Dec 12, 2025 and Dec 12, 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
- Physical Resistance/Sticking1
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.
MalfunctionDec 12, 2025Break; Device Difficult to Setup or Prepare; Physical Resistance/Sticking; Break; Device Difficult to Setup or Prepare; Physical Resistance/Sticking
IT WAS REPORTED THAT WHEN THE PRELOADED TORIC INTRAOCULAR LENS (IOL) WAS PUSHED INTO THE CARTRIDGE THE LEADING HAPTIC WAS TWISTED WHILE THE TRAILING HAPTIC WAS SLIGHTLY BENT, AND ABNORMAL TACKING WAS OBSERVED. THE HAPTICS ADHERED TO THE OPTIC, AND IT TOOK MORE THAN FIVE MINUTES TO SEPARATE THE HAPTICS FROM THE OPTIC USING A HOOK OR A SIMILAR INSTRUMENT. THE PLUNGER DID NOT READILY SEPARATE FROM THE IOL. THE PATIENT'S POSTOPERATIVE VISUAL ACUITY WAS REPORTED AS GOOD. THE INJECTOR HAD BEEN SET UP IMMEDIATELY PRIOR TO IMPLANTATION; OPHTHALMIC VISCOELASTIC DEVICE (OVD) WAS INJECTED THROUGH THE HYDRATION PORT AND THE PLUNGER WAS ADVANCED AT A NORMAL SPEED WITHOUT ISSUE. AFTER SETUP, THE IOL WAS INSERTED INTO THE EYE WITHOUT WAITING. THROUGH FOLLOW-UP, WE LEARNED THAT THE IOL WAS IMPLANTED IN THE PATIENT'S RIGHT EYE AND NO MEDICAL COMPLICATIONS OCCURRED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23796924 ↗
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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