TECNIS ODYSSEY IOL DRN00V (REF DRN00V0335)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS ODYSSEY SIMPLICITY 33.5D · Class 3 · Implant
All models of TECNIS ODYSSEY IOL (49)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05050474811034), received between Jan 27, 2026 and Jan 27, 2026 — classified as 1 injury.
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
Patient problems
- Blurred Vision1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 27, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S RIGHT EYE. THE PATIENT STATED THAT THEIR DISTANCE VISION WAS VERY BLURRY. THE DOCTOR PLANNED ON REMOVING THE IOL AT A LATER DATE (B)(6) 2025 AND REPLACING IT WITH THE SAME MODEL BUT DIFFERENT DIOPTER, DRN00V 31.0 DIOPTER. REPORTEDLY, THERE WERE NO COMPLICATIONS SUCH AS A CAPSULE TEAR, INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES. THEIR PREOPERATIVE UNCORRECTED AND BEST CORRECTED VISUAL ACUITY WAS REPORTED AS ¿COUNT FINGERS UNCORRECTED AND 20/25 CORRECTED.¿ THEIR POSTOPERATIVE UNCORRECTED AND BEST CORRECTED VISUAL ACUITY WAS REPORTED AS ¿20/120 UNCORRECTED AND 20/25 CORRECTED.¿ THE INITIAL IOL WAS SUBSEQUENTLY REMOVED. THE REPLACEMENT LENS INFORMATION WAS NOT PROVIDED BY THE CUSTOMER AND THE PATIENT OUTCOME IS UNKNOWN. CONSEQUENTLY, FOR THE OTHER EYE, THE DOCTOR PERFORMED AN ADJUSTMENT TO THEIR CALCULATIONS TO ACCOUNT FOR THE PATIENT¿S MYOPIC SURPRISE WITH THE FIRST LENS IN THE RIGHT EYE. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Blurred Vision
MAUDE report 24196617 ↗
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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