Clareon PanOptix Pro PXCAT6 (REF PXCAT6.160)Recalls & reported problems
Alcon Laboratories, Inc. · CLRN PO PRO TORIC ATME UVA · Class 3 · Implant
All models of Clareon PanOptix Pro (222)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380658492717), received between Mar 13, 2026 and Mar 13, 2026 — classified as 1 injury.
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 Problem1
Patient problems
- Visual Disturbances1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem
AN OPHTHALMIC SURGEON FROM A CLINICAL STUDY SITE REPORTED THAT THE PATIENT EXPERIENCED SEVERE HALOS FOLLOWING INTRAOCULAR LENS (IOL) IMPLANTATION. DETAILS OF THE PATIENT¿S POSTOPERATIVE VISITS ARE PROVIDED BELOW: (B)(6) 2026: THERE WAS NO IMPROVEMENT IN HALOS. THE DOCTOR RECOMMENDED USING ARTIFICIAL TEARS FOUR TIMES A DAY FOR TWO WEEKS TO DETERMINE IF THE SYMPTOMS IMPROVE. (B)(6) 2026: FOLLOW UP DETERMINED NO IMPROVEMENT IN SYMPTOMS WITH ARTIFICIAL TEARS. (B)(6) 2026: A HARD CONTACT LENS OVER REFRACTION COMPLETED FOR A CONTACT LENS TRIAL TO DETERMINE IF SYMPTOMS IMPROVE. (B)(6) 2026: PATIENT CALLED STATING NO IMPROVEMENT IN SYMPTOMS WITH CONTACT LENS TRIAL. THE DOCTOR RECOMMENDED EXCHANGING THE DOMINANT EYE LENS FIRST.
Patient problems: Visual Disturbances
MAUDE report 24587949 ↗
Other Lens, Multifocal Intraocular devices
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular144 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular1 recall66 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular113 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular112 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular110 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular107 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular104 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular93 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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