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	Blurred Vision (2137)
Date of Event	05/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product has not been returned to the manufacturing site.Based on the results from the product and batch history record, the product met release criteria.Root cause cannot be identified at this time.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 the following: the surgery was performed, there was no issue to the patient after the surgical procedure, but after a week, the patient's vision was decreased significantly, which did not meet the standard.The target was accurate, but the lens was exchanged due to the patient's complaint.No further information received.
Additional Manufacturer Narrative
The lens was returned for evaluation.Solution is dried on the lens.The lens was cut in half, typical of removal from the eye.A small scratch is observed, on the optic.Scrape marks are observed, on the optic.A small crack is observed, on anterior surface of the optic.Power and resolution inspection could not be conducted, due to extensive damage.Associated products were not provided.It is unknown, if qualified products were used.The root cause for the reported events could not be determined.A malfunction has not been indicated, or information provided, that the lens was the cause of the event.The customer indicated, that the target was accurate, but the lens was exchanged, due to the patient's complaint.The 24.0 diopter was removed.The replacement lens information was not provided.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
• MDR Report Key: 12229298
• Report Number: 1119421-2021-01462
• Device Sequence Number: 14329889
• Product Code: POE
• UDI-Device Identifier: 00380652421317
• UDI-Public: 00380652421317
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2021

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: 02/17/2025
• Device Model Number: DFT015
• Device Lot Number: 15038908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2021
• Initial Date Received by Manufacturer: 06/28/2021
• Supplement Date Received by Manufacturer: 09/20/2021
• Initial Report FDA Received Date: 07/27/2021
• Supplement Report FDA Received Date: 10/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention