Clareon CCWTT5 (UDI 00380652458597)Recalls & reported problems
Alcon Laboratories, Inc. · Clareon PanOptix 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 00380652458597), received between Apr 10, 2025 and Apr 10, 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
- Adverse Event Without Identified Device or Use Problem1
- Device Dislodged or Dislocated1
Patient problems
- Insufficient Information1
- Posterior Capsule Opacification1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 10, 2025Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem
A NURSE REPORTED THAT THE PATIENT HAD AN RLE (REFRACTIVE LENS EXCHANGE) IN BOTH EYES WITH A COMPANY LENS. AFTER 2 MONTHS, IT WAS NOTICED THAT THE LENS AXIS SHIFTED FROM 92 TO 110 AFTER IMPLANTING THE LENS. THEREFORE, THE LENS WAS ROTATED BACK FROM 92 TO 88 THREE WEEKS POST-ROTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH THIS PATIENT. THIS FILE BELONGS TO LEFT EYE.
Patient problems: Insufficient Information; Posterior Capsule Opacification
MAUDE report 21815137 ↗
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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 13, 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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