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

Model Number	TFNT30
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	05/14/2021
Type of Reportable Event	Malfunction
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.Additional information has been requested.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported that following implantation of an intraocular lens (iol) the lens had a small circle in the patient after 2-month implantation.The patient experienced decrease visual acuity and double vision.Additional information was requested.
Additional Manufacturer Narrative
Two photos were provided of an artifact on the iol.Unable to determine if the artifact is a bubble or damage from the provided photos.The artifact is located above the center of the optic.Clinical review provided by gqca: the likelihood that the reported ¿small circle appearance on the company lens,¿ identified by the arrows on both photographs, is related to the reported patient symptoms of decreased visual acuity and double vision, is inconclusive.Qualified associated products were indicated.The likelihood that the reported ¿small circle appearance on the lens,¿ identified by the arrows on both photographs, is related to the reported patient symptoms of decreased visual acuity and double vision, is inconclusive.More information was requested, but no response was received.File will be reopened if new information is provided.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was requested and received stating about the patient experienced double vision at distance and was corrected with glass -0.50d as a result the double vision was less.

• 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: 12023565
• Report Number: 1119421-2021-01231
• Device Sequence Number: 4338924
• Product Code: MFK
• UDI-Device Identifier: 00380652390002
• UDI-Public: 00380652390002
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/02/2025
• Device Model Number: TFNT30
• Device Catalogue Number: TFNT30.215
• Device Lot Number: 15074831
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/27/2021
• Supplement Date Received by Manufacturer: 10/07/2021
• Initial Report FDA Received Date: 06/18/2021
• Supplement Report FDA Received Date: 10/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1