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	Visual Impairment (2138); Visual Disturbances (2140)
Date of Event	03/24/2025
Type of Reportable Event	Serious Injury
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).
Event or Problem Description
A facility representative reported that patient experienced visual disturbance and worsening visual acuity after implantation.Additional information has been requested and received stating that the patient experienced visual disturbance and clinical reason for explant being worsening visual acuity after implantation.The iol was explanted and exchanged for an unknown advanced technology intraocular lens (atiol) following the initial implant procedure.It was noted that, visual acuity had improved, but still had some glare.There are two medical reports associated with this patient.This is for right eye.
Additional Manufacturer Narrative
The lens was returned submerged in clear liquid inside a small specimen jar.The lens was allowed to air dry prior to evaluation.Residue of clinical solution was observed on the lens.The optic was cut into pieces, typical of an insertion and removal.The optic center had cracked damage in the shape of an instrument used to grasp the lens.The damage was present on the anterior and directly opposite on the posterior surface.Three other areas of the optic edge had cracked damage in the shape of an instrument used to grasp the lens.The damage was present on the anterior and directly opposite on the posterior surface and travelled inward toward the center of the optic.The power and resolution of the returned lens could not be re-evaluated due to the optic damage.Product history records were reviewed and documentation indicated the product met release criteria.A qualified cartridge was used.The handpiece and viscoelastic information was not provided.It is unknown if qualified products were used.The root cause cannot be determined for the reported complaint.The explanted lens was returned cut into pieces, typical of an insertion and removal.The optic center and three other optic areas had lines of cracked damage in the shape of an instrument used to grasp the lens, present on the anterior and posterior optic surfaces.Each lens is subjected to a 100% assessment of the power (spherical and cylinder) and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.The power and resolution of the returned lens could not be re-evaluated due to the optic damage.The company lens 16.0 diopter (1.5 extended depth of focus) lens was removed.The replacement lens information was not provided.File will be reopened if new information is received.The manufacturer internal reference number is: (b)(4).

• 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; 246 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 22115560
• Report Number: 1119421-2025-01554
• Device Sequence Number: 7157417
• Product Code: POE
• UDI-Device Identifier: 00380652405690
• UDI-Public: (01)00380652405690(17)280327(11)240329(10)15829570
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2025

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 Model Number: CCWET0
• Device Lot Number: 15829570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/05/2025
• Supplement Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 05/30/2025
• Supplement Report FDA Received Date: 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2024
• 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: MONARCH III IOL, CARTRIDGE D.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown