TECNIS ODYSSEY IOL DRN00V (REF DRN00V0120)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS ODYSSEY SIMPLICITY 12.0D · 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 05050474810600), received between Dec 15, 2025 and Sep 29, 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 Problem2
Patient problems
- Eye Injury1
- Halo1
- Visual Disturbances1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Eye Injury
MAUDE report 50926896 ↗InjuryDec 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PRELOADED MULTIFOCAL INTRAOCULAR LENSES (IOLS), MODEL DRN00V, WERE IMPLANTED BILATERALLY. POSTOPERATIVELY THE PATIENT ACHIEVED EXCELLENT VISUAL ACUITY BUT EXPERIENCED INTOLERABLE GLARE WITH ASSOCIATED HALOS, PROMPTING EXPLANTATION OF BOTH MULTIFOCAL IOLS DURING A SECONDARY PROCEDURE. EACH EYE WAS SUBSEQUENTLY IMPLANTED WITH A LIGHT ADJUSTABLE LENS. THE POSTOPERATIVE OUTCOME FOLLOWING THE EXCHANGE WAS NOT PROVIDED. NO PATIENT OR USER HARM WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED. THE PATIENT UNDERWENT BILATERAL INTRAOCULAR LENS IMPLANTATION. THIS REPORT PERTAINS TO THE RIGHT EYE. A SEPARATE REPORT WILL BE SUBMITTED FOR THE LEFT EYE.
Patient problems: Halo; Visual Disturbances
MAUDE report 23812715 ↗
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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