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); Photophobia (4801); Posterior Capsule Opacification (4807)
Date of Event	06/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A consumer reported that following the intraocular lens (iol) implant procedure, the patient experienced both blurred near and distance vision.Patient could not see road signs and did not tolerate the fluorescent lighting.The patient also experienced glare, flickering and was unable to focus.The sight did not improve much and experienced mild posterior capsule opacification.The iol was centered.The patient was relying on glasses in order to sharpen her vision.There are two medical device reports associated with this file.This report is associated with the left eye.
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 documentation indicated the product met release criteria.The product investigation could not identify a root cause for the reported complaint.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 reporter was the patient.The implanting surgeon suggested lasik or an exchanged to a monofocal.Information was provided that the patient received a 2nd opinion and has opted to not proceed with lasik (laser-assisted in situ keratomileusis)or with an iol(intraocular lens) exchange.Patient hopes to eventually adapt to the lenses.File will be reopened if new information is received the manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information received that patient opted second opinion and doesn't want to proceed with any lasik or with iol exchange.She wants to keep lenses and eventually adapt to lenses.

• 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: 19457336
• Report Number: 1119421-2024-01057
• Device Sequence Number: 7870659
• Product Code: POE
• UDI-Device Identifier: 00380652405782
• UDI-Public: (01)00380652405782(17)260801(11)220803(10)15459499(21)15459499027
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2024

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: 08/01/2026
• Device Model Number: CCWET0
• Device Catalogue Number: CCWET0.205
• Device Lot Number: 15459499
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/06/2024
• Supplement Date Received by Manufacturer: 07/11/2024
• Initial Report FDA Received Date: 06/04/2024
• Supplement Report FDA Received Date: 08/08/2024
• Date Device Manufactured: 08/03/2022
• 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: Other
• Patient Age: 71 YR
• Patient Sex: Female