Clareon CCWET0 (UDI 00380652405812)Recalls & reported problems
Alcon Laboratories, Inc. · Clareon Vivity UVA · Class 3 · Implant
All models of Clareon (1142)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Alcon Clareon Vivity UVA is an intraocular lens implanted during cataract surgery to replace the eye's natural lens. Most of the 26 reports describe blurred or unclear vision, glare and halos, and dizziness after surgery, and in20 of them the lens was taken out and replaced with another one; some mention scratches or defects noticed on the lens. There are no deaths and no recalls naming this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 26
- Deaths reported
- 0
- Injuries reported
- 20
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00380652405812), received between Jul 15, 2022 and Apr 11, 2026 — classified as 20 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (4 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem17
- Scratched Material4
- Material Split, Cut or Torn2
- Use of Incorrect Control/Treatment Settings2
- Break1
- Inaccurate Delivery1
Patient problems
- Blurred Vision11
- Visual Impairment7
- Visual Disturbances5
- Insufficient Information4
- No Clinical Signs, Symptoms or Conditions3
- Dizziness2
- Eye Injury2
- Headache2
Recent adverse event reports
The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 11, 2026Scratched Material
A HEALTH CARE PROFESSIONAL REPORTED THAT SCRATCH OR DEFECT WAS NOTICED ON THE LENS AFTER IT WAS INSERTED INTO THE LEFT EYE. THE LENS WAS REMOVED AND REPLACED WITH A NEW ONE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24846027 ↗InjuryApr 6, 2026Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PROCEDURE WAS PERFORMED ON THE PATIENT¿S LEFT EYE, AND NO PATIENT HARM OCCURRED.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 24791673 ↗InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED UNCLEAR VISION AND INTENSE GLARE/HALOS. DUE TO THESE DEBILITATING SYMPTOMS, WHICH INTERFERED WITH DAILY FUNCTIONING, THE LENS WAS EXPLANTED AND REPLACED WITH AN UNSPECIFIED MONOFOCAL IOL DURING A SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED, YET NO NEW INFORMATION RECEIVED.
Patient problems: Blurred Vision; Visual Disturbances
MAUDE report 24766978 ↗InjuryDec 26, 2025Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings
A FACILITY REPRESENTATIVE REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT CAN'T TOLERATE DIZZINESS AND NAUSEA. THE LENS WAS EXPLANTED AND REPLACED WITH COMPANY LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS GOAL PLANO, GOT PLANO. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Dizziness; Nausea
MAUDE report 23896159 ↗InjuryDec 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS EXCHANGED FOR AN UNKNOWN MONOFOCAL IOL AFTER THE INITIAL IMPLANT PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS PATIENT APPEARS TO BE INTOLERANT OF AN EXTENDED DEPTH OF FOCUS IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Impairment
MAUDE report 23827757 ↗InjuryNov 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT EXPERIENCED BLURRY VISION IN ALL FIELDS. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ADVANCED TECHNOLOGY INTRAOCULAR LENSES IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS UNDER CORRECT ASTIGMATISM/ INCORRECT IOL SELECTION ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 23486824 ↗InjuryMay 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS UNABLE TO TOLERATE AND BLURRY VISION. CLINICAL REASON WAS RELATED TO RETINAL DETACHMENT REPAIR, AND INTOLERANCE TO EXTENDED DEPTH OF FOCUS OF IOL. THE IOL WAS EXCHANGED FOR 6 MONTHS 1 WEEK 6 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE.
Patient problems: Blurred Vision
MAUDE report 22106970 ↗InjuryMay 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS EXPLANTED WITH PATIENT REASON MENTIONED MECHANICAL COMPLICATION. THE LENS WAS EXPLANTED AND EXCHANGED WITH ANOTHER LENS 5 MONTHS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21967253 ↗MalfunctionApr 17, 2025Scratched Material; Scratched Material
NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED SCRATCH AFTER THE IOL WAS IMPLANTED INTO THE EYE. THE LENS WAS EXPLANTED DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION RECEIVED AND STATED THAT THE PROCEDURE WAS COMPLETED AND STATED THAT THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21855791 ↗MalfunctionFeb 20, 2025Scratched Material; Scratched Material
A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SCRATCH ON LENS WAS NOTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21419437 ↗InjuryJan 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS HAVING STROBING LIGHTS. CLINICAL REASON IS PATIENT EXPERIENCING DYSPHOTOPSIA. THE IOL WAS EXCHANGED FOR MONOFOCAL INTRA OCULAR LENS 2 MONTHS 2 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Disturbances
MAUDE report 21066042 ↗MalfunctionSep 24, 2024Use of Incorrect Control/Treatment Settings; Scratched Material; Use of Incorrect Control/Treatment Settings; Scratched Material
ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT SURGEON INSERTED WRONG DIOPTER FOR PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20293227 ↗InjurySep 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD MALADAPTATION. THE IOL WAS EXCHANGED FOR UNSPECIFIED LENS MODEL 4 MONTHS 09 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR EXPLANT WAS REPORTED AS MALADAPTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision
MAUDE report 20123652 ↗InjuryAug 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON HEALTH CARE, PROFESSIONAL REPORTED, THAT AFTER SURGERY. THE PATIENT, EXPERIENCED POOR VISION. CLINICAL REASON BEING MENTIONED, AS INTOLERANT OF VISION QUALITY. THE IOL WAS EXPLANTED AND EXCHANGED, FOR AN UNKNOWN ATIOL. FOLLOWING THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Impairment
MAUDE report 20062781 ↗InjuryMay 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED HEADACHES DIZZINESS, IMBALANCE. CLINICAL REASON FOR EXPLANT IS MYOPIC SURPRISE. THE IOL WAS EXCHANGED FOR ADVANCED TECHNOLOGY INTRAOCULAR LENS (ATIOL) MODEL 5 MONTHS 1 DAY FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Balance Problems; Dizziness; Headache; Visual Impairment
MAUDE report 19296486 ↗InjuryMay 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED VISION NOT CLEAR BEYOND 9 FEET, LOOKS LIKE WATER WHEN LOOKING DOWN AND HEADACHES. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 01 MONTH 24 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS DYSPHOTOPSIA AND SHIMMERING. ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT PATIENT STRUGGLED WITH NEGATIVE DYSPHOTOPSIAS AND OTHER UNUSUAL VISUAL PHENOMENON. PATIENT ISSUES ARE IMPROVED FOLLOWING AN IOL EXCHANGE AND THERE WAS NO PATIENT HARM.
Patient problems: Blurred Vision; Headache; Visual Disturbances
MAUDE report 19249030 ↗InjuryMar 22, 2024Break; Break
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, UPON INSERTION OF THE LENS TRAILING HAPTIC RIPPED AND A NEW LENS WAS REPLACED BUT THE INCISION WAS ENLARGED TO EXPLANT THE DAMAGED LENS AND SUTURE WAS PLACED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Eye Injury
MAUDE report 18958097 ↗InjuryMar 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION AND GLARE. THE LENS WAS EXPLANTED AND REPLACED WITH MONOFOCAL LENS IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Blurred Vision; Visual Disturbances
MAUDE report 18874792 ↗InjuryFeb 29, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE CUT OR TEAR WAS NOTICED NEAR THE CENTRAL OPTICAL ZONE OF THE IOL. THIS WAS NOT RECOGNIZED UNTIL IOL IN CAPSULAR BAG. SUBSEQUENTLY, THE LENS WAS REMOVED WITH SLIGHT ENLARGED INCISION DURING INITIAL PROCEDURE AND THE PROCEDURE WAS COMPLETED WITH ANOTHER IOL. ADDITIONAL INFORMATION WAS RECEIVED AND REPORTED THAT THERE WAS NO PATIENT HARM.
Patient problems: Eye Injury
MAUDE report 18812614 ↗InjuryOct 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD BLURRY VISION BOTH DISTANCE AND NEAR. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL 6 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS POST OPERATIVE ASTIGMATISM, ANISOMETROPIA. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment
MAUDE report 17903217 ↗InjurySep 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED DECREASED VISION . THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL 10 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision
MAUDE report 17823102 ↗InjurySep 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED POOR NEAR VISION. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL 2 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS INSUFFICIENT NEAR VISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision
MAUDE report 17676450 ↗InjuryAug 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION THE PATIENT HAD EXPERIENCED POOR QUALITY VISION BOTH IN NEAR AND DISTANCE VISION. HENCE THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AND WAS REPLACED WITH AN UNSPECIFIED MONOFOCAL LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE PHYSICIAN WAS NOT SURE IF THE PRODUCT HAD CAUSED THE EVENT. THERE WAS NO HARM TO THE PATIENT. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT.
Patient problems: Blurred Vision
MAUDE report 17467303 ↗MalfunctionJan 11, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND PATIENT DETAILS WERE RECEIVED.
Patient problems: Insufficient Information
MAUDE report 16141576 ↗MalfunctionDec 15, 2022Inaccurate Delivery; Inaccurate Delivery
A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) PROCEDURE, THE IOL FELL OUT OF PATIENT EYE. THE PROCEDURE WAS COMPLETED WITH ANOTHER IOL DURING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 15986170 ↗
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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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