Clareon CCWET5 (UDI 00380652456012)Recalls & reported problems
Alcon Laboratories, Inc. · Clareon Vivity Toric UVA · Class 3 · Implant
All models of Clareon (1142)
Data updated Oct 16, 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 00380652456012), received between Sep 9, 2025 and Sep 9, 2025 — 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Blurred Vision1
- Visual Impairment1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT HAD POOR VISION AND ASTIGMATISM, EVEN AFTER REPOSITIONING IOL 2 WEEKS AFTER INITIAL PLACEMENT. THE REST OF EYE EXAM WAS NORMAL. ADDITIONAL INFORMATION RECEIVED STATING THAT PATIENT HAS HAD BLURRY VISION AND ASTIGMATISM EVER SINCE SURGERY EVEN AFTER REPOSITIONING IOL 2 WEEKS AFTER INITIAL PLACEMENT, AND THE REST OF EYE EXAM WAS NORMAL LEAVING TO DEDUCE A POSSIBLE ISSUE WITH THE LENS. THE OTHER ISSUE WAS THAT PATIENT'S IOL MEASUREMENTS WERE SUBOPTIMAL BUT THEY WERE ALREADY LOOKING INTO THIS SEPARATELY. IN THE SURGEON¿S OPINION THE PRODUCT CONTRIBUTED TO THE EVENT. PATIENT'S ISSUES NOT RESOLVED. THE SURGEON¿S PROGNOSIS WAS POOR VISION WAS EXPECTED UNLESS IOL IS REMOVED AND REPLACED WITH MONOFOCAL LENS.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 23012169 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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