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	02/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation summary: the product was not returned for analysis.The product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A facility representative reported that following an intraocular lens (iol) implantation procedure, the patient experienced fuzzy distance vision and was overcorrected on the minus side.The iol was exchanged approximately 2 months after the initial implantation.Additional information has been requested.
Additional Manufacturer Narrative
Based on information received following submission of the initial report that the iol was not the cause of the event and that the iol was exchanged for a different diopter, this event does not meet criteria for reporting as a serious injury.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was provided indicating that in the surgeon¿s opinion the iol did not cause or contribute to the event.The event was caused by a refractive surprise.The iol was exchanged for the same model with a 1.5 difference of diopter power.The patient¿s issues have resolved.The prognosis is excellent.

• 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: 11752194
• Report Number: 1119421-2021-00927
• Device Sequence Number: 4138117
• Product Code: POE
• UDI-Device Identifier: 00380652421218
• UDI-Public: 00380652421218
• 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: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2021

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: 08/25/2025
• Device Model Number: DFT015
• Device Lot Number: 15093881
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/08/2021
• Supplement Date Received by Manufacturer: 05/04/2021
• Initial Report FDA Received Date: 04/30/2021
• Supplement Report FDA Received Date: 05/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR