Clareon CCWTT4 (UDI 00380652457842)Recalls & reported problems
Alcon Laboratories, Inc. · Clareon PanOptix Toric UVA · 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 00380652457842), received between Dec 7, 2022 and May 25, 2023 — classified as 2 injuries.
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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Blurred Vision1
- Halo1
- Visual Disturbances1
- 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 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NURSE REPORTED THAT AFTER INTRAOCULAR LENS (IOL) IMPLANTATION, THE PATIENT HAD HALOS, STARBURST AND CLOUDY PERIPHERY. THE LENS WAS EXPLANTED AND REPLACED WITH NON-COMPANY LENS IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION RECEIVED STATED THAT PATIENT'S RIGHT EYE WAS INVOLVED AND THE PATIENT'S ISSUES HAD BEEN RESOLVED.
Patient problems: Blurred Vision; Halo; Visual Disturbances
MAUDE report 17002680 ↗InjuryDec 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PURCHASING MANAGER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS EXPLANTED DUE TO INCORRECT LENS POWER. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AFTER APPROXIMATELY ONE MONTH OF INITIAL IMPLANTATION. IT WAS REPORTED THAT A 16.5 DIOPTER LENS WAS EXCHANGED FOR A 14.5 DIOPTER SAME MODEL LENS. THERE WERE NO VITRECTOMY OR SUTURE OF LENS WAS NEEDED, OR NO INCISION ENLARGEMENT NEEDED. IT WAS REPORTED THAT SUTURE OF INCISION NEEDED AND CAPSULE BAG INTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Impairment
MAUDE report 15937372 ↗
Other intraocular lens devices
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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