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

Model Number	TFAT00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138)
Date of Event	12/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility representative reported that following an intraocular lens (iol) implant procedure, the patient was unhappy with near vision.The iol was exchanged for unspecified monofocal lens.Clinical reason for explant mentioned as slight hyperopic prescription following surgery.Additional information has been requested, received and stated the patient's vision was overall not clear.The iol was exchanged for another company lens.There was no patient harm.
Additional Manufacturer Narrative
The lens was returned adhered to the end of the plunger inside a syringe.The plunger was fully advanced, pressed against the end of the syringe.Blood and solution were dried on the lens.One haptic was bent in the gusset and distal area.The other haptic was broken from the gusset area (not returned).The optic was torn (possibly cut) from edge past center.Power and resolution testing could not be conducted due to the extensive optic damage.Product history records were reviewed and documentation indicated the product met release criteria.The attached completed questionnaire indicated the use of a handpiece that is qualified for the lens when used with a qualified cartridge combination.The associated cartridge and viscoelastic were not provided.It is unknown if a qualified product was used.The product investigation could not identify a root cause for the reported complaint.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 multifocal company 22.0 diopter, add power +2.2 & 3.2 lens model was replaced with a non-company monofocal 22.0 diopter lens.Due to the exchange of a multifocal lens to a monofocal lens, the replacement lens may have been 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 UV ABSORBING 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: 19499123
• Report Number: 1119421-2024-01104
• Device Sequence Number: 7907534
• Product Code: MFK
• UDI-Device Identifier: 00380652429757
• UDI-Public: 00380652429757
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/10/2024

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 Model Number: TFAT00
• Device Catalogue Number: TFAT00.220
• Device Lot Number: 15397344
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2024
• Initial Report FDA Received Date: 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2022
• 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: BAUSCH AND LOMB MX60E 22.0, SN 3Q04540017; MONARCH III IOL DELIVERY SYSTEM, INJECTOR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male