Clareon CCWTT4 (UDI 00380652458047)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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380652458047), received between Mar 7, 2023 and Mar 10, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (2 reports).
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
- Material Split, Cut or Torn2
Patient problems
- Insufficient Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 10, 2026Material Split, Cut or Torn
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A CRACK WAS OBSERVED NEAR THE CENTER OF THE OPTIC, WHICH APPEARED TO HAVE RESULTED FROM PRESSURE AFTER THE LENS EXITED THE CARTRIDGE. THE COMPANY¿S INJECTOR WAS USED TOGETHER WITH A COMPATIBLE CARTRIDGE, WHICH IS THE APPROPRIATE CONFIGURATION. THE SURGEON IMMEDIATELY CUT OUT AND REMOVED THE LENS. NO HARM TO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE LENS WAS REPLACED WITH ANOTHER LENS FROM THE SAME COMPANY, WITH THE SAME MODEL AND DIOPTER.
Patient problems: Insufficient Information
MAUDE report 24556029 ↗MalfunctionMar 7, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING A CATARACT EXTRACTION WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS HAD A RIP IN IT OR WAS TORN. THEN THE LENS WAS REMOVED DURING INITIAL SURGERY. ADDITIONAL INFORMATION WAS RECEIVED STATING LENS WAS SENT BACK, IT DID NOT GET IMPLANTED/REMOVED. NO OTHER DATA WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 16493715 ↗
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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