MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ VIVITY EXTENDED VISION UV ABSORBING IOL; INTRAOCULAR LENS

Model Number	DAT015
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	02/16/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample device was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non-healthcare professional reported that following an intraocular lens (iol) implant procedure, the patient experienced blurry vision.The clinical reason was refractive error.The iol was explanted and exchanged in a secondary procedure for a monofocal lens.Additional information has been requested and received stated that patient had blurred vision at all distances and had the trouble with adaptation to the multi focal lens.There was no patient harm.The surgeon prognosis was good, the patient was not hospitalized and the issue has been resolved.
Additional Manufacturer Narrative
The account indicated the use of a qualified associated cartridge and viscoelastic.The handpiece used if only qualified for use with company lens models.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.Information was provided that the company lens, 23.0 diopter, (1.5 extended depth of focus) was replaced with a non-company, 22.0 diopter, monofocal lens model.The product was not returned for evaluation.Additional information was provided that, in the surgeon's opinion, the product did not cause or contribute to the event.It was reported that the event was due to a refractive error and that the patient had "trouble with adaptation to the multifocal." no additional information has been provided at this time.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ VIVITY EXTENDED VISION UV ABSORBING IOL
• Common Device Name: 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: 15710055
• Report Number: 1119421-2022-02327
• Device Sequence Number: 12417176
• Product Code: POE
• UDI-Device Identifier: 00380652424691
• UDI-Public: 00380652424691
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2023

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: 09/28/2025
• Device Model Number: DAT015
• Device Lot Number: 15103049
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2022
• Supplement Date Received by Manufacturer: 12/13/2022
• Initial Report FDA Received Date: 11/01/2022
• Supplement Report FDA Received Date: 01/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2020
• 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: CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR.; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown