Clareon CCWET0 (UDI 00380652405874)Recalls & reported problems
Alcon Laboratories, Inc. · Clareon Vivity UVA · Class 3 · Implant
All models of Clareon (1142)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652405874), received between Oct 12, 2023 and Jul 9, 2024 — classified as 3 injuries, 1 malfunction.
The most frequently reported specific device problem is “Defective Device” (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 Problem2
- Defective Device1
- Device Dislodged or Dislocated1
- Material Split, Cut or Torn1
Patient problems
- Blurred Vision3
- Diplopia/Double Vision1
- Insufficient Information1
- Visual Impairment1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJul 9, 2024Device Dislodged or Dislocated; Material Split, Cut or Torn; Device Dislodged or Dislocated; Material Split, Cut or Torn
A NURSE REPORTED THAT DURING SURGERY, THEY NOTICED THAT LENS WAS DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED DOUBLE VISION UNDERSIDE MORE BLURRY AND CLINICAL REASON FOR EXPLANT BEING DECREASED VISION, DOUBLE VISION, DISLOCATED IOL. THE IOL WAS EXPLANTED AND EXCHANGED FOR A SAME MODEL AND DIOPTER COMPANY LENS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION RECEIVED STATING THAT THEY DID A PREMIUM IOL ON THIS PATIENT LEFT EYE ON (B)(6) 2024. AT HER SAME DAY POSTOP THE LENS WAS NOTED TO BE DISLOCATED. FOUND THAT THE INITIAL LENS WAS DAMAGED- HAPTIC WAS TORN WHICH LED TO THE DISLOCATION AND WAS ABLE TO EXCHANGE IT AND PLACED A NEW COMPANY IOL. EVERYTHING WENT FINE.
Patient problems: Blurred Vision; Diplopia/Double Vision
MAUDE report 19698860 ↗InjuryApr 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION WAS RECEIVED. THERE WAS NO PATIENT HARM.
Patient problems: Blurred Vision
MAUDE report 19132203 ↗MalfunctionDec 22, 2023Defective Device; Defective Device
A FACILITY REPRESENTATIVE REPORTED THAT DURING SURGERY, THEY NOTICED THAT LENS WAS DAMAGED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18382590 ↗InjuryOct 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL 4 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS MYOPIC SURPRISE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 17922520 ↗
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- 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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