MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ NATURAL SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number	SN60WF
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A product 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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non health care professional reported that following an intraocular lens (iol) implant procedure, the patient experienced blurry vision.Clinical reason being mentioned as hyperopic refractive outcome.The iol was explanted and exchanged for an unknown monofocal lens following the secondary implant procedure.Additional information has been received it states that there was no impact to the patient.The iol was explanted and exchanged with another company lens following the secondary implant procedure.
Additional Manufacturer Narrative
The product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.An intraocular lens (iol) exchange for a difference equal to or greater than two diopters, indicates the event is most likely related to a calculation error.The account indicated the product was not available to evaluate.Each lens is subjected to a 100 percent 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 20.5 diopter lens was replaced with a company 25.0 diopter lens due to a reported hyperopic refractive outcome.It was reported the patient had pre-existing chronic uveitis and posterior synechiae.Based on the information provided, the event does not appear to be related to the product.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ NATURAL SINGLEPIECE 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: 20642102
• Report Number: 1119421-2024-02177
• Device Sequence Number: 7506553
• Product Code: HQL
• UDI-Device Identifier: 00380655093207
• UDI-Public: (01)00380655093207(17)270727(11)220729(10)15458301
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2025

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: SN60WF
• Device Catalogue Number: SN60WF.205
• Device Lot Number: 15458301
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2024
• Supplement Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 01/14/2025
• Date Device Manufactured: 07/29/2022
• 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: UNK CARTRIDGE, HANDPIECE, OVD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male