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

Model Number	DFT315
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	06/09/2021
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 the documentation indicated the product met release criteria.The root cause has not been identified.No other complaints for lot.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A nurse reported that following an intraocular lens (iol) implant procedure, the patient felt hard to focus and visual images were not sharp.The iol was exchanged in a secondary procedure for a different manufacturer¿s monofocal iol approximately 2 months following the initial procedure.Additional information has been requested.

• Brand Name: ACRYSOF IQ VIVITY TORIC EXTENDED VISION IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 12340750
• Report Number: 1119421-2021-01588
• Device Sequence Number: 14586576
• Product Code: POE
• UDI-Device Identifier: 00380652421621
• UDI-Public: 00380652421621
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/19/2021

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: 05/21/2025
• Device Model Number: DFT315
• Device Lot Number: 15073909
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/23/2021
• Initial Report FDA Received Date: 08/19/2021
• 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: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE; REPLACEMENT IOL:B&L LI61AO, 17.5, 4853602045
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR