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	05/23/2022
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 non healthcare professional reported that following implantation the patient experienced distance vision, fuzzy/hazy, twitching/blurred and failed frequent lubrication.Additional information was provided stating patient used the otc(over the counter) artificial tears and 2 different rx eye drops to help lubricate the eye without success/patient was using artificial tears.
Additional Manufacturer Narrative
Correction g.3: supplemental medical device report (smdr) #1 manufacturing report number (1119421-2022-02107) is being filed to correct the g.3 date on the initial report, filed earlier.Incorrect date of (b)(6) 2022 is being corrected to (b)(6) 2022.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was provided that, in the surgeon's opinion, a quality issue with the iol did not cause or contribute to the event.In the surgeon's opinion, the event was caused by the "lens rotated post op day 0 to 1." no further information was provided and lens was explanted.
Additional Manufacturer Narrative
The account indicated the use of a qualified associated cartridge and viscoelastic.The handpiece indicated is not qualified for the lens/cartridge combination used.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 the 20.0 diopter (add power +2.2/+3.2) lens was replaced with a 19.0 diopter (add power +2.2/+3.2) lens.The product was not available for evaluation.Additional information was provided that, in the surgeon's opinion, a quality issue with the iol did not cause or contribute to the event.In the surgeon's opinion, the event was caused by the "lens rotated post op day 0 to 1." no further information was provided.The manufacturer internal reference number is: (b)(4).

• 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
• 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: 15526916
• Report Number: 1119421-2022-02107
• Device Sequence Number: 11389524
• Product Code: MFK
• UDI-Device Identifier: 00380652357739
• UDI-Public: 00380652357739
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/07/2022

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: 01/10/2026
• Device Model Number: TFNT00
• Device Catalogue Number: TFNT00.200
• Device Lot Number: 15124237
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/09/2022
• Supplement Date Received by Manufacturer: 10/04/2022; 10/14/2022
• Initial Report FDA Received Date: 10/03/2022
• Supplement Report FDA Received Date: 10/05/2022; 11/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CLAREON MONARCH IV IOL INJECTOR; DISCOVISC; MONARCH III IOL CARTRIDGE D
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 63 YR
• Patient Sex: Male