Clareon CNWET0 (UDI 00380652405102)Recalls & reported problems
Alcon Laboratories, Inc. · Clareon Vivity · Class 3 · Implant
All models of Clareon (1142)
Data updated Oct 16, 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 00380652405102), received between Aug 7, 2025 and Sep 28, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Material Deformation” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Material Deformation1
Patient problems
- Insufficient Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Material Deformation
Patient problems: Insufficient Information
MAUDE report 50915645 ↗InjuryAug 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NURSE REPORTED THAT AFTER INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AFTER TWO WEEKS OF POST OPERATION THE PATIENT EXPERIENCED INTOLERABLE GLARE AND HALOS BY THE COMPANY LENS SO, THE PATIENT WAS NOT ABLE TO DRIVE DURING THE DAY OR AT NIGHT. EVEN STREETLIGHTS HAD RINGS AROUND THEM. DUE TO THE SURGERIES, THE PATIENT ALSO HAD INDUCED ASTIGMATISM IN THIS EYE. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS WITH DIFFERENT MODEL IN A SECONDARY PROCEDURE. PATIENT ALSO UNDERWENT YAG (YTTRIUM-ALUMINUM-GARNET) LASER AFTER THE EXCHANGE AND NEED A REFRACTIVE TOUCH UP WITH PRK (PHOTOREFRACTIVE KERATECTOMY). IN THE SURGEON'S OPINION, THE PROGNOSIS OF THE PATIENT WAS GOOD. THERE WAS NO FURTHER IMPACT TO THE PATIENT.
Patient problems: Insufficient Information
MAUDE report 22739408 ↗
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- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens145 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens144 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens139 reports
- TECNIS SIMPLICITY DIB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens1 recall81 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens129 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens127 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens126 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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