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

Model Number	TFNT30
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned.Product history records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause for the reported complaint.The product was not returned.Each lens is subjected to a 100% assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.Information was provided that initially, the reporter (patient) was extremely pleased, but distance sight has deteriorated a lot over time.This may indicate the issue is unrelated to the iol (intraocular lens).The reporter was encouraged to speak with their surgeon.The reporter does not want company to contact the surgeon.File will be reopened if new information is received.There are no other complaints in this lot.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A consumer reported that following an intraocular lens (iol) implant procedure, the patient was not happy with the iol.Additional information was received and stated that initially, the consumer was extremely pleased, but distance sight has deteriorated a lot over time.The patient felt that her vision has gone back to where it was before surgery.She complained to doctor and was not happy with his explanations.She has to wear glasses for distance, not my aim at all, while reading and mid vision was very good.She would have rather the opposite.Additional information received and stated that she can see very well to read but can not see well at distance.She states she was having problems to drive and could not see street signs.
Additional Manufacturer Narrative
The product was not returned.Product history records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause for the reported complaint.The product was not returned.Each lens is subjected to a 100% assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.Information was provided that initially, the reporter (patient) was extremely pleased, but distance sight has deteriorated a lot over time.This may indicate the issue is unrelated to the iol (intraocular lens).The reporter was encouraged to speak with their surgeon.The reporter does not want company to contact the surgeon.File will be reopened if new information is received.There are no other complaints in this lot.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A consumer reported that following an intraocular lens (iol) implant procedure, the patient was not happy with the iol.Additional information was received and stated that initially, the consumer was extremely pleased, but distance sight has deteriorated a lot over time.The patient felt that her vision has gone back to where it was before surgery.She complained to doctor and was not happy with his explanations.She has to wear glasses for distance, not my aim at all, while reading and mid vision was very good.She would have rather the opposite.Additional information received and stated that she can see very well to read but can not see well at distance.She states she was having problems to drive and could not see street signs.

• 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
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 13590208
• Report Number: 1119421-2022-00347
• Device Sequence Number: 6062294
• Product Code: MFK
• UDI-Device Identifier: 00380652415484
• UDI-Public: 00380652415484
• Combination Product (Y/N): N
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/24/2022

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: 01/27/2025
• Device Model Number: TFNT30
• Device Catalogue Number: TFNT30U180
• Device Lot Number: 15021521
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/08/2022
• Initial Report FDA Received Date: 02/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female