TECNIS ODYSSEY TORIC II IOL DRT150 (REF DRT1500115)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TEC ODYSSEY TOR II SMPCY 11.5D 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 05050474811188), received between Dec 10, 2025 and Jan 26, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Scratched Material” (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
- Scratched Material1
Patient problems
- Blurred Vision1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 26, 2026Scratched Material
IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S LEFT EYE. THE SURGEON NOTICED A SCRATCH ON THE LENS AND CUT IT OUT. A SECOND IOL OF THE SAME MODEL WAS INSERTED. THERE WAS DELAY IN THE PROCEDURE. THERE WERE NO COMPLICATIONS SUCH AS A CAPSULE TEAR VITRECTOMY, UNPLANNED SUTURES, OR MEDICATION OUTSIDE THE STANDARD OF CARE. THE SECOND LENS ENDED UP GETTING STUCK IN THE LOADER. THE SURGEON HAD TO CUT OPEN THE SECOND PRELOADED LENS AND MANUALLY LOAD THE IT INTO A PLATINUM CARTRIDGE AND INJECTOR. THE CUSTOMER REPORTED, ¿ IMPLANTATION OF THE SECOND LENS WENT FINE¿. THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24185739 ↗InjuryDec 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AFTER THE PRELOADED MUTLIFOCAL TORIC INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE RIGHT EYE, THE PATIENT EXPERIENCED BLURRY VISION AT ALL DISTANCES, RESULTING IN THE LENS BEING EXPLANTED IN A SECONDARY SURGERY. THE ISSUE WAS FIRST OBSERVED DURING A POST-OPERATIVE EXAMINATION. A NON-JOHNSON AND JOHNSON IOL WITH A +13.5 DIOPTER WAS IMPLANTED AS REPLACEMENT. THERE WAS NO UNPLANNED INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES REQUIRED. NO ADDITIONAL MEDICAL ATTENTION OR MEDICATION PRESCRIBED OUTSIDE OF STANDARD OF CARE WAS REQUIRED. THERE WAS NO DELAY IN PROCEDURE. THE DIRECTIONS FOR USE WERE FOLLOWED. PRE-OPERATIVELY, THE BEST CORRECTED VISUAL ACUITY (BSCVA) WAS 20/25 AND 20/20 POST-OPERATIVELY. THE PATIENT WAS OVERCORRECTED BUT DID NOT LOSE TWO OR MORE LINES OF BSCVA. THERE WERE NO PRE-EXISTING CONDITIONS WHICH AFFECTED THE LENS CALCULATION. THE INTENDED TARGET REFRACTION WAS -0.39. THE POST-OPERATIVE REFRACTION AFTER LENS EXCHANGE WAS 20/20. THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Blurred Vision
MAUDE report 23772849 ↗
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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