Clareon CNW0T6 (UDI 00380652411325)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 00380652411325), received between Oct 24, 2025 and Oct 24, 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
- Material Opacification2
Patient problems
- Blurred Vision1
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 24, 2025Material Discolored; Material Opacification; Material Discolored; Material Opacification
A PHYSICIAN REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, DURING THE INITIAL SURGERY ON (B)(6) 2025, AN OILY FILM-LIKE SHEEN WAS OBSERVED ACROSS THE ENTIRE IOL SURFACE WHEN IOL WAS INSERTED. REMOVAL WAS ATTEMPTED USING IRRIGATION AND ASPIRATION (IA), BUT IT COULD NOT BE REMOVED, SO THE LENS WAS REPLACED WITH A BACKUP LENS. A SLIGHT SHEEN WAS ALSO OBSERVED ON THE REPLACED LENS, BUT THE SURGERY WAS COMPLETED WITH SAME LENS. ON (B)(6) 2025, DURING A POSTOPERATIVE EXAMINATION, THE PATIENT REPORTED A CLOUDY OR HAZY SENSATION, AS IF LOOKING THROUGH A FOG. THE PATIENT IS SCHEDULED FOR A FOLLOW-UP VISIT ON (B)(6) 2025.
Patient problems: Blurred Vision
MAUDE report 23380210 ↗MalfunctionOct 24, 2025Material Discolored; Material Opacification; Material Discolored; Material Opacification
A PHYSICIAN REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, DURING THE INITIAL SURGERY ON (B)(6) 2025, AN OILY FILM-LIKE SHEEN WAS OBSERVED ACROSS THE ENTIRE IOL SURFACE WHEN IOL WAS INSERTED. REMOVAL WAS ATTEMPTED USING IRRIGATION AND ASPIRATION (IA), BUT IT COULD NOT BE REMOVED, SO THE LENS WAS REPLACED WITH A BACKUP LENS. A SLIGHT SHEEN WAS ALSO OBSERVED ON THE REPLACED LENS, BUT THE SURGERY WAS COMPLETED WITH SAME LENS. ON (B)(6) 2025, DURING A POSTOPERATIVE EXAMINATION, THE PATIENT REPORTED A CLOUDY OR HAZY SENSATION, AS IF LOOKING THROUGH A FOG. THE PATIENT IS SCHEDULED FOR A FOLLOW-UP VISIT ON (B)(6) 2025.
Patient problems: Insufficient Information
MAUDE report 23380205 ↗
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- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens129 reports
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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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