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)
Date of Event	01/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The explanted lens has not returned.If the sample becomes available the file will be reopened and updated.Product history records were reviewed and documentation indicated the product met release criteria.Information was provided that a qualified cartridge and a non-qualified viscoelastic were used.The handpiece information was not provided.The root cause may be unrelated to the lens and related to patient.The completed questionnaire indicated that in the surgeon's opinion for what caused the event: patient unable to adapt to lens.Information indicated that even with the lri performed her vision was only slightly improved.The patient would like the lens exchanged and removed.Information was provided that the company 23.0 diopter ( 1.5 extended depth of focus) lens.Lens was removed and replaced with a non-company monofocal lens (+25.00 diopter).This information that an extended depth of focus lens was exchanged for a monofocal lens would also support that the replacement lens was an improved selection for this patient's vision needs or preferences.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 manufacturer internal reference number is: (b)(4).
Event or Problem Description
A nurse reported that after intraocular lens (iol) implant procedure, the patient's vision was worse then prior to surgery.The lens was explanted and replaced with a monofocal lens 2 months after the initial procedure.The clinical reason for explant was poor distance and near vision.Additional information has been requested and received stating the patient was not seeing well at a distance or near.Limbal relaxing incisions performed but her vision was only slightly improved.The patient was still struggling with near tasks as well as computer, so the lens explant was performed.The surgeon's prognosis was good.

• 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: 16545029
• Report Number: 1119421-2023-00461
• Device Sequence Number: 6453074
• Product Code: POE
• UDI-Device Identifier: 00380652405836
• UDI-Public: 00380652405836
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/15/2023

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: 04/23/2026
• Device Model Number: CCWET0
• Device Catalogue Number: CCWET0.230
• Device Lot Number: 15386877
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/20/2023
• Initial Report FDA Received Date: 03/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2022
• 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: AMVISC PLUS OVD; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female