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	07/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A non-healthcare professional reported that following an intraocular lens (iol) implant procedure, the patient vision is not crisp and clear.The iol was exchanged for unspecified lens model 3months and 11 days after the initial implant procedure.Clinical reason for explant was reported as visual disturbances.Additional information has been requested.
Additional Manufacturer Narrative
The lens was returned in a cylindrical specimen tube.Viscoelastic and blood were dried on the lens.The optic was cut and broken into pieces, typical of an insertion and removal.The lens was cleaned with klrp for further evaluation.The optic portions had additional areas of the lens material that were cracked.Product history records were reviewed and documentation indicated the product met release criteria.A qualified cartridge and handpiece were used with a non qualified viscoelastic.The root cause was determined to be related to the patient.The questionnaire indicated that the lens did not cause or contribute to the event.Per the questionnaire, in the surgeon's opinion the product was not a good fit for this patient.The lens was returned cut and broken into pieces with additional optic damage.Each lens was subjected to a 100percentage assessment of the power 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 21.5 diopter (1.5 extended depth of focus) lens was removed and replaced with a monofocal.The specific model and diopter of the replacement lens was not provided.Due to the exchange of a company model 21.5 diopter for a monofocal lens, this suggests that the monofocal replacement lens may have been an improved choice for the patient's vision needs.The 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; 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: 21417910
• Report Number: 1119421-2025-00446
• Device Sequence Number: 18473463
• Product Code: POE
• UDI-Device Identifier: 00380652405805
• UDI-Public: (01)00380652405805(17)271119(11)231121(10)15752951
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/19/2025

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 Catalogue Number: CCWET0.215
• Device Lot Number: 15752951
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2025
• Initial Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2023
• 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 CARTRIDGE D; MONARCH III INJECTOR; VISCOELASTIC: HEALON S5
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown