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

Model Number	TFAT30
Health Effect - Clinical Codes	Dry Eye(s) (1814); Blurred Vision (2137); Visual Disturbances (2140); Halo (2227)
Date of Event	01/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lens was returned on a folded white piece of paper inside a plastic bag.Viscoelastic and fibers from the paper were observed on the lens.The optic was cut into two portions, typical in appearance to damage created to facilitate removal from the eye.The optic has a small gouge and scratched on the anterior surface.Product history records were reviewed and documentation indicated the product met release criteria.Information was provided that indicated the use of a qualified cartridge and handpiece.A non-qualified viscoelastic was indicated.The root cause cannot be determined for the reported event.The explanted lens was returned in pieces with additional damage.The power and resolution of the returned lens could not be evaluated due to the optic damage.The power and resolution of each lens is 100% evaluated during the manufacturing process to determine acceptability per model and diopter.Based on our observation it can be reasonably concluded that the damage is not manufacturing related.Due to the presence of surgical solution and the condition of the returned sample, the damage is most likely related to customer handling.Follow up information indicated that in the surgeon¿s opinion, an iol quality issue did not cause or contribute to the event.Information was provided that the toric 19.5 diopter (add power +2.2/+3.2) lens was replaced with a toric 19.5 diopter (1.5 extended depth of focus) lens.This information may suggest that the replacement lens was a better selection for the patient's vision needs or preferences.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A nurse reported following the intraocular lens implantation the patient had experienced blurred vision both near and distance along with the halos around the lights.The lens was explanted in a secondary procedure.The clinical reason given for the explant was mild irregular steepening on topos, which may be part of blurriness.Additional information has been requested and received stating the patient had experienced dry eye and aggressive eye drops were given to help with it.There was no harm to the patient.

• Brand Name: ACRYSOF IQ PANOPTIX TORIC 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: 14209806
• Report Number: 1119421-2022-00859
• Device Sequence Number: 4170638
• Product Code: MFK
• UDI-Device Identifier: 00380652418690
• UDI-Public: 00380652418690
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/26/2022

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: 07/04/2026
• Device Model Number: TFAT30
• Device Catalogue Number: TFAT30.195
• Device Lot Number: 15227096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 04/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2021
• 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: MONARCH III CARTRIDGE C.; MONARCH III IOL INJECTOR.; NUVISC.; UNSPECIFIED EYE DROPS.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female