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

Model Number	DAT015
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	07/20/2021
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 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 nurse reported that following implantation of an intraocular lens (iol) the patient vision was not sharp/feels vision not crisp even with manifest refraction (mrx), macula optical coherence tomography was fine.Additional information was requested and received stated approximately after 2 months the lens was explanted with a monofocal lens in a secondary procedure.
Event or Problem Description
There was no patient harm and hospitalization.Postoperative the patient stopped taking ketorolac and used artificial tears frequently.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ VIVITY EXTENDED VISION UV ABSORBING IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 12517994
• Report Number: 1119421-2021-01814
• Device Sequence Number: 5121949
• Product Code: POE
• UDI-Device Identifier: 00380652424691
• UDI-Public: 00380652424691
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,Followup
• Report Date (Section B): 11/03/2021

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: 10/19/2025
• Device Model Number: DAT015
• Device Lot Number: 15108796
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/02/2021
• Supplement Date Received by Manufacturer: 10/29/2021
• Initial Report FDA Received Date: 09/23/2021
• Supplement Report FDA Received Date: 11/03/2021
• 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 CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM,INJECTOR; PROVISC; TECNIS ZCB00 23.0; MONARCH III CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM,INJECTOR; PROVISC; TECNIS ZCB00 23.0
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR