Clareon CCWET4 (UDI 00380652486101)Recalls & reported problems
Alcon Laboratories, Inc. · Clareon Vivity Toric UVA · Class 3 · Implant
All models of Clareon (1142)
Data updated Oct 16, 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 00380652486101), received between Jun 13, 2025 and Jun 13, 2025 — classified as 1 injury.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated1
Patient problems
- Blurred Vision1
- Visual Impairment1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 13, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
A PHYSICIAN REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT'S POST OPERATIVE VISION WAS 20/60 AND THE LENS HAD ROTATED TO 27 DEGREE AXIS WITH REFRACTION -1.76 +3.00 X95. THE SURGEON HAD USED 10 DIOPTER LENS AT 90 DEGREES INITIALLY. SO, THE DOCTOR RAN ASTIGMATISM FIX AND IT SAID TO ROTATE THE LENS BACK TO 80 DEGREES SO THE PATIENT WOULD END UP ABOUT -0.50 +0.50 X80. THE PATIENT HAD AN APPOINTMENT FOR HIS SECOND EYE ON (B)(6) AND THE DOCTOR WAS THINKING TO ROTATE THE LENS ON THE SAME DAY. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT, THE LENS GOT ROTATED AFTER SURGERY WHICH WAS LARGER THAN NORMAL AL. THE DOCTOR THEN RE-ROTATED THE LENS AND THE PATIENT WAS DOING BETTER. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT, THE DIAGNOSIS OF THE HARM WAS BLURRY UNCORRECTED VISION WITH MORE ASTIGMATISM, THE PATIENT'S ISSUE WAS NOT RESOLVED, THE LENS WAS ROTATED TO THE CORRECT AXIS BUT THEN IT RE ROTATED OUT OF THE POSITION AGAIN BY 1 WEEK AFTER THE SURGERY. THE LENS WHICH ROTATED OUT OF THE POSITION FOR THE SECOND TIME WAS NOT FIXED.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 22204465 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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