Clareon CNW0T7 (UDI 00380652411622)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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380652411622), received between Aug 24, 2023 and Jan 13, 2026 — classified as 2 injuries.
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
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Blurred Vision2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Visual Disturbances1
- Visual Impairment1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem
A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT HAD BLURRED VISION NOT GETTING BETTER, SHADOWS AROUND LETTERS, SIGNS AND DIFFERENT OBJECTS. PATIENT COULD NOT SEE LEAVES ON TREES AND IOL OVER-CORRECTED ASTIGMATISM. PLANNED TO REPLACE WITH AN UNKNOWN ADVANCED TECHNOLOGY INTRAOCULAR LENS (ATIOL).
Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment
MAUDE report 24053451 ↗InjuryAug 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED THAT AFTER IMPLANTATION OF INTRAOCULAR LENS, THE PATIENT'S VISUAL ACUITY WAS MEASURED IN JUNE AFTER SURGERY, THE VISUAL ACUITY WAS NOT GOOD. NON-INFLAMMATORY CELLS WERE ADHERED ON FRONT OF IOL OVER ALMOST THE ENTIRE CIRCUMFERENCE OF THE IOL. YAG CAPSULOTOMY WAS PERFORMED. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THE PATIENT HAD RESIDUAL ASTIGMATISM THOUGH TORIC IOL WAS IMPLANTED. THE PHYSICIAN CONSIDERED THAT THIS SYMPTOM WAS FROM LENS EPITHELIAL CELLS AFTER RECEIVING THE INFORMATION THAT THIS CASES WERE SIMILAR TO LENS EPITHELIAL CELL ON-GROWTH (LECOG). IN ADDITIONAL, THE PHYSICIAN SUSPECTED THAT THIS SYMPTOM MIGHT BE RELATED WITH TRABECULECTOMY 30 YEARS AGO (INFLAMMATORY RESPONSE). THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision
MAUDE report 17610538 ↗
Other intraocular lens devices
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- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens145 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens144 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens139 reports
- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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