Clareon CCWTT4 (UDI 00380652458108)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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380652458108), received between Dec 15, 2022 and May 15, 2023 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Crack” (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.
Most reported problems
Device problems
- Crack1
- Device Dislodged or Dislocated1
Patient problems
- Blurred Vision1
- Halo1
- Insufficient Information1
- 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 15, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
A OTHER HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED POOR NIGHT VISION. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL 3 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. THE CLINICAL REASON FOR EXPLANT MENTIONED AS DIFFICULTY TO ADAPT THE MULTIFOCAL LENS. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT PATIENT BEGAN COMPLAINING ABOUT SYMPTOMS ASSOCIATED WITH MULTIFOCALITY AT THE 1 WEEK POST OPERATION VISIT. PATIENT VISION REMAINED SC 20/20 NV 6 POINT UNTIL THE 1 MONTH POST OPERATIVE VISIT WHERE HER SC DV WAS 30/30-BLURRY AND REFRACTED TO +0.75 SPH. THE REFRACTIVE ERROR ALONG WITH GLARE AND HALOS WAS THE REASON FOR EXPANT. IN SURGEON¿S OPINION BOTH THE MULTIFOCALITY AND POSSIBLE IOL SHIFT CAUSED THE EXPLANT.
Patient problems: Blurred Vision; Halo; Visual Disturbances; Visual Impairment
MAUDE report 16929342 ↗MalfunctionDec 15, 2022Crack; Crack
A FACILITY REPRESENTATIVE REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE CRACKED LENS AND LENS WAS EXPLANTED DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED PATIENT DETAILS.
Patient problems: Insufficient Information
MAUDE report 15987507 ↗
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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