MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ PANOPTIX TRIFOCAL IOL; LENS, MULTIFOCAL

Model Number	TFNT00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	04/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product evaluation: product history records were reviewed and documentation indicated the product met release criteria.No other complaints reported for the lot number.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A nurse reported an explanted iol with reason "blurry vision.".
Additional Manufacturer Narrative
The customer indicated the use of qualified associated products.In the surgeon's opinion the lens did not cause or contribute to the event.The surgeon's opinion was that, "there was more power left in os prescription than originally planned for so it was causing blurry vision." the 17.0 diopter (add power +2.2/+3.2) lens was replaced with a 18.0 diopter (add power +2.2/+3.2) lens.It was also indicated the patient had pre-existing pvd and drusen ou.No additional information has been provided at this time.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A facility representative reported that post implantation of an intraocular lens (iol) the patient experienced blurry vision.The iol was exchanged in a secondary procedure 19 months following the initial implantation.Additional information was received states that the surgeons opinion there was more power left in os prescription than originally planned for so it was causing blurry vision.

• Brand Name: ACRYSOF IQ PANOPTIX TRIFOCAL IOL
• Common Device Name: LENS, MULTIFOCAL
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 12041379
• Report Number: 1119421-2021-01247
• Device Sequence Number: 19880591
• Product Code: MFK
• UDI-Device Identifier: 00380652414937
• UDI-Public: 00380652414937
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2021

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: 04/30/2024
• Device Model Number: TFNT00
• Device Catalogue Number: TFNT00U170
• Device Lot Number: 12712665
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/27/2021
• Supplement Date Received by Manufacturer: 07/22/2021
• Initial Report FDA Received Date: 06/22/2021
• Supplement Report FDA Received Date: 08/16/2021
• 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: ACRYSOF IQ; MONARCH III CARTRIDGE D; MONARCH III, INJECTOR; PROVISC
• Outcome Attributed to Adverse Event: Required Intervention