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 Codes	Fall (1848); Intraocular Pressure Increased (1937); Visual Impairment (2138)
Date of Event	05/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
An accountant reported that following an intraocular lens (iol) implant procedure, the patient experienced poor vision.The lens was explanted in a secondary procedure after 5 weeks of initial implantation.The clinical reason for the explant was myopic shift.Additional information was received stating on post of day 7 intraocular pressure (iop) was elevated at that visit to 33.He was started on beta blocker medication.At 2 weeks post op, iop was 23.At 5 weeks post op, he was having significant issues with visual functioning and had a fall with no serious harm.Iop was normal at 16.At this visit, physician made the decision to replace the lens.Patient is now seeing 20/20 with new lens and is happy with vision.
Additional Manufacturer Narrative
The lens was returned in a specimen cup.Solution was dried on the lens.Both haptics were bent in the distal area.The optic was cut into pieces, typical of insertion and removal.Power and resolution testing could not be conducted due to the extensive optic damage.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Qualified associated products were indicated.There have been no other complaints reported in the lot number.The product investigation could not identify a root cause for the reported complaint.Power and resolution testing could not be conducted due to the extensive optic damage.The power and resolution of each lens is 100% evaluated during the manufacturing process to determine acceptability per model and diopter.Information was provided that the 10.5 diopter, add power +2.2 & 3.2 lens model was replaced with a 09.5 diopter, add power +2.2 & 3.2 lens model.The exchange for a 1.0 lower diopter difference of the same lens model may suggest that the replacement lens was an improved choice for the patient's vision needs.No additional information has been provided at this time 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: 15051747
• Report Number: 1119421-2022-01579
• Device Sequence Number: 14827915
• Product Code: MFK
• UDI-Device Identifier: 00380652414807
• UDI-Public: 00380652414807
• Combination Product (Y/N): N
• Initial Reporter State: AK
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/19/2022

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: 01/31/2024
• Device Model Number: TFNT00
• Device Catalogue Number: TFNT00U105
• Device Lot Number: 12691915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/21/2022
• Initial Report FDA Received Date: 07/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2019
• 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: ISTENTS; MONARCH III CARTRIDGE D; MONARCH III INJECTOR; ORA; PROVISC
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male