TECNIS ODYSSEY IOL DRN00V (REF DRN00V0290)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS ODYSSEY SIMPLICITY 29.0D · Class 3 · Implant
All models of TECNIS ODYSSEY IOL (49)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474810945), received between Feb 7, 2025 and Feb 2, 2026 — classified as 2 injuries.
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
- Visual Disturbances2
- Blurred Vision1
- Halo1
- 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.
InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem
THE DRN00V MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S EYE. POST-OPERATIVELY, THE PATIENT ACHIEVED GOOD VISUAL ACUITY: 20/15 - OCULUS UTERQUE (OU - BOTH EYES) AND J1+; HOWEVER, EXPERIENCED SIGNIFICANT HALO AND GLARE, PARTICULARLY AT NIGHT. THE LENS WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A LIGHT ADJUSTABLE IOL (LAL). THERE WAS NO PATIENT INJURY DURING THE LENS EXCHANGE PROCEDURE; HOWEVER, PATIENT PROGNOSIS POST IOL EXPLANT IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Halo; Visual Disturbances
MAUDE report 24229205 ↗InjuryFeb 7, 2025Scratched Material; Scratched Material
IT WAS REPORTED THAT AFTER THE PRELOADED INTRAOCULAR LENS (IOL) WAS IMPLANTED THE SURGEON NOTICED A DEFECT THAT LOOKED LIKE A CHIP OR SCRATCH ON THE PERIPHERY OF THE LENS. THE SURGEON DECIDED AGAINST REMOVAL DUE TO THE ASSOCIATED RISKS (EXPLANT WOULD HAVE OUTWEIGHED THE BENEFIT, DISCOMFORT OR VISUAL ISSUES NOTICED). THE SCRATCHED WAS DESCRIBED TO BE ABOUT 0.5 MM FROM THE OPTIC EDGE, FAR ENOUGH ON THE PERIPHERY WHERE THE SURGEON FELT IT WAS OUT OF THE VISUAL AXIS.
Patient problems: Blurred Vision; No Clinical Signs, Symptoms or Conditions; Visual Disturbances
MAUDE report 21333854 ↗
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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