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

Model Number	TFNT40
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	05/18/2021
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 consumer reported that following bilateral intraocular lens (iol) implant procedures, he cannot read small print and cannot see anything over 2 blocks away, it's too blurry.He describes vision as just being fuzzy, not clear.Has to have ambient light to read up close, but can if prompted.Surgeon says to wait for adaptation period.States his eye are improving as scheduled, but patient is not happy.There are 2 medical device reports associated with this event.This report is for the right eye.Additional information has been reported.
Additional Manufacturer Narrative
Additional information provided in b.5.H.3.And h.10.Information was provided that the patient has indicated the surgeon has said to wait for adaptation period.Surgeon states eyes are improving as scheduled.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was requested, received and reported that the patient was still very upset and frustrated that things have not improved.

• Brand Name: ACRYSOF IQ PANOPTIX TORIC TRIFOCAL IOL
• Common Device Name: LENS, MULTIFOCAL
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 12315497
• Report Number: 1119421-2021-01559
• Device Sequence Number: 11908613
• Product Code: MFK
• UDI-Device Identifier: 00380652416030
• UDI-Public: 00380652416030
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2021

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: 08/31/2024
• Device Model Number: TFNT40
• Device Catalogue Number: TFNT40U190
• Device Lot Number: 12744598
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/16/2021
• Supplement Date Received by Manufacturer: 08/17/2021
• Initial Report FDA Received Date: 08/12/2021
• Supplement Report FDA Received Date: 09/09/2021
• 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: Other