TECNIS ODYSSEY IOL DRN00V (REF DRN00V0300)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS ODYSSEY SIMPLICITY 30.0D · 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 05050474810969), received between Feb 7, 2025 and Feb 2, 2026 — classified as 2 injuries.
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
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Halo2
- Visual Disturbances2
- Blurred Vision1
- Unspecified Eye / Vision Problem1
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 24229180 ↗InjuryFeb 7, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THE DRN00V0300 WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE). POST-OPERATIVELY, THE PATIENT REPORTS SHE IS SEEING THREE (03) RINGS AROUNDS LIGHTS AND HEADLIGHTS AND CANNOT DRIVE AT NIGHT. VISUAL CLARITY IS GOOD AND BLURRINESS IS OFF AND ON BUT GETTING BETTER IN BOTH EYES. IN ADDITION, BOTH EYES FEEL TIRED. PATIENT STATES THE IOL FEELS LIKE A CONTACT IS IN HER EYE AND SHE CAN SEE THE EDGE IF IT IN THE BOTTOM LEFT CORNER. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT REMAINS IMPLANTED. NO FURTHER INFORMATION IS AVAILABLE. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Blurred Vision; Halo; Unspecified Eye / Vision Problem; Visual Disturbances
MAUDE report 21330675 ↗
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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