Clareon CCW0T5 (UDI 00380652433815)Recalls & reported problems
Alcon Laboratories, Inc. · CLAREON 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 00380652433815), received between Mar 25, 2024 and Apr 29, 2026 — classified as 2 injuries.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated1
- Device Markings/Labelling Problem1
Patient problems
- Insufficient Information2
- Eye Injury1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 29, 2026Device Dislodged or Dislocated
A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL WAS EXCHANGED FOR DIFFERENT DIOPTER AND MODEL COMPANY LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS LENS DISPLACEMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THERE WAS NO PATIENT HARM.
Patient problems: Insufficient Information
MAUDE report 25027445 ↗InjuryMar 25, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem
A HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS INITIALLY PLANNED TO IMPLANT WAS 13.0 D TORIC MODEL (T6) LENS. AFTER ORA MEASUREMENT, DECIDED TO IMPLANT A LENS WITH A SLIGHTLY LOWER CYLINDER POWER OF 13.0 D. THAT'S WHAT SWITCHED THE ORDER TO FROM WITHIN THE OPERATING ROOM. THE CIRCULATING NURSE WENT TO GET IT. WHEN NURSE CAME BACK, CARRIED A COMPANY LENS 13.0 D. SURGEON WAS ONLY FOCUSED ON THE SPHERICAL POWER (13.0 D) AND THE TORIC MODEL (T5) AND COMPLETELY FAILED TO SEE THAT COMPANY LENS MODEL NAME. IN FACT, SURGEON WAS NOT EVEN AWARE THAT A LENS OF THIS MODEL WAS IN THEIR CONSIGNMENT. THE INCISION WAS WIDENED BY 0.5 MM USING A KNIFE. THE INTRAOCULAR LENS WAS FOLDED INSIDE THE EYE WAS REMOVED WITH LENS INSERTION FORCEPS. THE CORRECT LENS WITH CYLINDER POWER WAS THEN RETRIEVED FROM THE LENS IMPLANT ROOM AND IMPLANTED DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY WITHOUT ANY HARM TO THE PATIENT.
Patient problems: Eye Injury; Insufficient Information
MAUDE report 18967159 ↗
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- 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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