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 Disturbances (2140)
Date of Event	11/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lens was returned with a triangular piece of medical sponge in a ziploc baggie.Solution was dried on the lens.The optic was cut into two pieces.Each optic portion contained a full, undamaged haptic.The anterior optic surface had light scratches near the optic edge and scratches directly opposite on the posterior surface.Additional scratches were observed near to the center on the anterior optic surface.A power and resolution re-test could not be conducted due to the optic returned in pieces.Product history records were reviewed and documentation indicated the product met release criteria.Information was provided that a qualified cartridge, handpiece, and viscoelastic were used.The root cause cannot be determined for the reported complaint.The lens was returned cut into two pieces, typical of an insertion and removal.Additional optic damage was observed.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.A power and resolution re-test could not be conducted due to the lens damage.Information was provided that the company lens 19.0 diopter (1.5 extended depth of focus) lens was removed and replaced with a non-company lens.This information may suggest that the replacement lens was an improved selection for this patient's vision needs or preferences.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A facility representative reported that following an intraocular lens (iol) implant procedure, the patient was dissatisfied with distance and fare negative dysphotopsia.The iol was exchanged for another lens model four months following the initial implant procedure.

• 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: 18866938
• Report Number: 1119421-2024-00443
• Device Sequence Number: 12796024
• Product Code: POE
• UDI-Device Identifier: 00380652405751
• UDI-Public: 00380652405751
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/08/2024

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: 01/30/2026
• Device Model Number: CCWET0
• Device Catalogue Number: CCWET0.190
• Device Lot Number: 15344772
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/12/2024
• Initial Report FDA Received Date: 03/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: LAL MODEL 60005 SN:70047950715; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; MONARCH IOL DELIVERY SYSTEM, CARTRIDGE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female