Clareon CNW0T9 (UDI 00380652412766)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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380652412766), received between Apr 20, 2026 and Apr 20, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Scratched Material” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Scratched Material1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 20, 2026Scratched Material
ADDITIONAL INFORMATION WAS REQUESTED AND IT WAS REPORTED THAT PRIOR TO IMPLANTATION, THE INTRAOCULAR LENS HAD BEEN INSPECTED IN ACCORDANCE WITH STANDARD PROCEDURES, WITH NO DEFECTS OR ABNORMALITIES IDENTIFIED AT THAT STAGE. REGARDING THE PRESENCE OF A POTENTIAL SCRATCH AND ITS FUNCTIONAL IMPACT, POSTOPERATIVE FOLLOW-UP INDICATED NO SIGNIFICANT VISUAL DISCOMFORT, AND THE BEST-CORRECTED VISUAL ACUITY REMAINED STABLE AT 8/10. THE POSSIBLE SCRATCH WAS REPORTED NOT TO BE LOCATED IN THE VISUAL AXIS, OR IF PRESENT, IT DID NOT RESULT IN ANY NOTICEABLE FUNCTIONAL IMPAIRMENT. BASED ON THE AVAILABLE FINDINGS, NO CONFIRMED DEFECT OF THE IMPLANT WAS IDENTIFIED. A MALFUNCTION OF THE INJECTOR COULD NOT BE ENTIRELY RULED OUT; HOWEVER, NO CLINICAL EVIDENCE SUPPORTED THIS HYPOTHESIS. AS A PRECAUTIONARY MEASURE, THE INJECTOR IN QUESTION WAS CONSIDERED FOR WITHDRAWAL FROM STOCK. THE POSTOPERATIVE COURSE WAS REPORTED AS FAVORABLE, WITH STABLE CONDITION, UNCHANGED OCT (OPTICAL COHERENCE TOMOGRAPHY) FINDINGS, AND NORMAL INTRAOCULAR PRESSURE. ROUTINE FOLLOW-UP WAS TO CONTINUE AS PER STANDARD PROTOCOL. IN VIEW OF THE ABSENCE OF FUNCTIONAL COMPLAINTS AND CLINICAL STABILITY, NO EXPLANTATION WAS PLANNED. AS P
Patient problems: Insufficient Information
MAUDE report 24927070 ↗
Other intraocular lens devices
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens146 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page