Clareon CNWET3 (UDI 00380652466288)Recalls & reported problems
Alcon Laboratories, Inc. · Clareon Vivity Toric · Class 3 · Implant
All models of Clareon (1142)
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 00380652466288), received between Jan 17, 2025 and May 6, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Device Dislodged or Dislocated1
Patient problems
- Blurred Vision2
- Visual Impairment1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT'S VISION WAS BLURRY. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS ETIOLOGY UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision
MAUDE report 21969039 ↗InjuryJan 17, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT EXPERIENCED BLURRED VISION. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS ROTATION OF THE LENS, MYOPIC SHIFT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT, ON POST-OPERATIVE WEEK 1VISIT, IT WAS NOTED THAT THE PATIENT VISION WAS 20/70 UNCORRECTED AND THE LENS ROTATED FROM 93 DEGREES (INITIAL IMPLANTATION AXIS) TO 44 DEGREES. THE PATIENT ALSO HAD A MYOPIC RESULT APPROXIMATELY -0.75 FROM WHERE THE TARGET WAS. IN THE SURGEON OPINION THE ROTATION WAS DUE TO THE FACT THAT THE PATIENT WAS A HIGH MYOPE (-9.50 PRE-OPERATIVE) AND WAS DIAGNOSED TO HAVE LOOSE ZONULES AFTER SURGERY. THERE WAS NO PATIENT HARM.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 21181045 ↗
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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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