Clareon CNW0T7 (UDI 00380652411714)Recalls & reported problems
Alcon Laboratories, Inc. · CLAREON BLF TORIC · 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 00380652411714), received between May 28, 2024 and Apr 29, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Discolored” (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 Discolored2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 29, 2025Material Discolored; Material Discolored
A PHYSICIAN REPORTED THAT AFTER IMPLANTATION OF LENS DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE IOL LOOKED BLUE IMMEDIATELY. THE SURGERY WAS COMPLETED WITHOUT PRODUCT REPLACEMENT. IT WAS UNKNOWN WHETHER THESE FINDINGS DISAPPEARED OR CONTINUED. THE LENS REMAINED IMPLANTED. THERE HAVE BEEN NO REPORTED HEALTH PROBLEMS OR HARM TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE. THERE ARE 224 MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS IS 121 OF 224.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21931764 ↗MalfunctionMay 28, 2024Material Discolored; Material Discolored
A PHYSICIAN REPORTED THAT DURING SURGERY, THEY NOTICED THAT LENS USED IN THE SURGERY HAD BECOME CLOUDY AFTER THE SURGERY. CURRENTLY, THE WHITE CLOUDING HAS CLEARED, WAS CLEAN, AND THERE WERE NO PROBLEMS WITH THE PATIENT'S VISION. CONFIRMATION WILL BE MADE ON THE PRODUCT, WHEN THE CLOUDING WAS PRESENT POSTOPERATIVELY, WHEN IT CLEARED UP, AND THE PATIENT'S CURRENT VISUAL ACUITY. THE LENS STILL REMAINS IN THE PATIENT'S EYE. THE IOL BECAME CLEAR THE DAY AFTER THE SURGERY. AS OF NOW, THE ASTIGMATISM WAS CORRECTED, AND VISION WAS FINE. THE PATIENT DID NOT HAVE ANY PARTICULAR DISEASES SUCH AS DIABETES. ALSO, NO DRUGS WERE USED THAT WERE DIFFERENT FROM THOSE USED FOR OTHER PATIENTS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19404439 ↗
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- 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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