Clareon CCWTT5 (UDI 00380652458344)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
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380652458344), received between Oct 14, 2022 and Jan 2, 2026 — classified as 2 injuries, 1 malfunction.
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
- Failure to Unfold or Unwrap1
- Use of Incorrect Control/Treatment Settings1
Patient problems
- Blurred Vision1
- No Clinical Signs, Symptoms or Conditions1
- Visual Disturbances1
- Visual Impairment1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJan 2, 2026Use of Incorrect Control/Treatment Settings; Device Dislodged or Dislocated
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION. THE IOL WAS EXCHANGED FOR UNSPECIFIED LENS MODEL 14 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR EXPLANT WAS REPORTED AS MECHANICAL ERROR OF IOL OR REFRACTIVE ERROR. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT SUBLUXED IOL. THE LENS WAS REPLACED WITH COMPANY LENS.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 23942556 ↗InjuryMar 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED WITH INTOLERABLE GLARE. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 04 MONTHS 16 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS PHOTOPSIAS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Disturbances
MAUDE report 18835260 ↗MalfunctionOct 14, 2022Failure to Unfold or Unwrap; Failure to Unfold or Unwrap
A NON HEALTH CARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANT PROCEDURE, IT WAS NOTED THAT THE LENS WAS DEFECTIVE. THE LENS WAS EXCHANGED DURING THE SAME PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED STATING DURING SURGERY, THE SURGEON PLACED THE LENS INSIDE THE PATIENT¿S EYE WHEN HE NOTICED THAT THE LENS WOULD NOT UNFOLD. THE LENS WAS REMOVED FROM THE PATIENT¿S EYE, A REPLACEMENT LENS WAS USED TO COMPLETE THE SURGERY THE SAME DAY. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15607927 ↗
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- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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