Clareon CNW0T7 (UDI 00380652402460)Recalls & reported problems
Alcon Laboratories, Inc. · CLAREON BLF TORIC · Class 3 · Implant
All models of Clareon (1142)
Data updated Oct 16, 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 00380652402460), received between Jan 17, 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Material Discolored2
- Device Contamination with Chemical or Other Material1
- Material Deformation1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
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 179 OF 224.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21927371 ↗MalfunctionJan 17, 2024Material Discolored; Device Contamination with Chemical or Other Material; Material Deformation; Material Discolored; Device Contamination with Chemical or Other Material; Material Deformation
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS SOMETHING LIKE A FLAT BURR AT THE ROOT OF THE IOL HAPTIC AFTER IMPLANTATION. CAST MOLDING WAS NOT COMPLETED, AND SURGEON SUSPECTED THAT THERE MAY HAVE BEEN SOME RAW MATERIAL LEFT OVER (HE DESCRIBED THAT IT IS LIKE THE WINGED DUMPLING). THE SURGERY WAS COMPLETED WITHOUT PRODUCT REPLACEMENT. THE LENS STILL REMAINS IN THE PATIENT'S EYE. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT, THE PHYSICIAN SUSPECTED THAT THE COLOR WAS SLIGHTLY DARKER AND PROTRUDES IN AN IRREGULAR SHAPE FROM THE BASE OF THE HAPTIC TO THE EDGE OF THE OPTICS.
Patient problems: Insufficient Information
MAUDE report 18527164 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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