MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON CLAREON VIVITY EXTENDED VISION UV ABSORBING IOL; EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS

Model Number	CCWET0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138); Visual Disturbances (2140); Halo (2227)
Type of Reportable Event	Serious Injury
Event or Problem Description
A consumer reported that after cataract surgery with intraocular lens (iol) implantation, she experienced blurry vision and halos.Her surgeon suggested that he will explant and replace with a monofocal lens.The lens was later removed in a secondary procedure.
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.Associated product information was not provided.The root cause cannot be determined for the reported complaint.The patient's stated reason was unable to tolerate extended depth of vision of intraocular lens (iol).The clinical reason given on the completed advanced technology intraocular lens (atiol) form for the explant was for "visual disturbances".Each lens is subjected to a 100% assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.The product was not returned for an evaluation.Information was provided that the lens was explanted and thrown away.The company vivity 20.0 diopter (1.5 extended depth of focus) lens was removed and replaced with a company monofocal diopter unknown lens.This information that the vivity extended depth of focus lens was replaced with a monofocal lens may suggest that the replacement lens was an improved selection for this patient's vision needs.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
According to additional information received, the patient was unable to tolerate the extended depth (ed) of iol.The lens was removed and replaced with a company lens in a secondary procedure.The clinical reason for explant was "visual disturbance".The patient also experienced fluctuating focus and glare.The explanted lens was discarded.

• Brand Name: CLAREON VIVITY EXTENDED VISION UV ABSORBING IOL
• Common Device Name: EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 19348901
• Report Number: 1119421-2024-00961
• Device Sequence Number: 17992864
• Product Code: POE
• UDI-Device Identifier: 00380652405775
• UDI-Public: 00380652405775
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/06/2026
• Device Model Number: CCWET0
• Device Catalogue Number: CCWET0.200
• Device Lot Number: 15428779
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/22/2024
• Supplement Date Received by Manufacturer: 06/07/2024
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 07/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female