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

Model Number	DFT015
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
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 physician reported that after implantation of intraocular lens (iol), the patient manifested refraction.Post operation it was determined that the patient would have a better outcome with a 16.5 diopter lens.The lens was explanted in a secondary procedure with a 16.5d lens.The patient was much happier after replacement.Additional information was requested, but no further information is available.
Additional Manufacturer Narrative
The root cause cannot be determined, for the reported complaint.The file indicated, the lens was explanted.The sample was not returned, for an evaluation.Based on the information provided in the initial report, the complaint may be related to a coincidental event unrelated to the quality of the lens.Information was provided in the file that a surgeon followed his pre-op plan.And implanted the correct lens for a patient complaint lens 17.5 diopter.Upon follow-up and post op manifest refraction, it was determined, that the patient would have a better outcome with a 16.5 diopter lens, so the surgeon performed an iol exchange.Indeed the patient is much happier.This information suggests that the replacement lens may have been a better selection for this patient's vision needs or preferences.While it is indicated, that a 16.5 diopter lens was used as the replacement lens.The specific lens model has not been confirmed.Multiple follow ups were attempted for additional information.No further information has been provided.If additional information becomes available, the file will be reopened and updated.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ VIVITY EXTENDED VISION 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: 15173247
• Report Number: 1119421-2022-01713
• Device Sequence Number: 6213040
• Product Code: POE
• UDI-Device Identifier: 00380652421188
• UDI-Public: 00380652421188
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2022

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: 11/04/2025
• Device Model Number: DFT015
• Device Lot Number: 15112283
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/14/2022
• Supplement Date Received by Manufacturer: 09/27/2022
• Initial Report FDA Received Date: 08/05/2022
• Supplement Report FDA Received Date: 10/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown