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

Model Number	TFAT30
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Disturbances (2140); Halo (2227)
Date of Event	02/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A nurse reported that following implantation of an intraocular lens (iol) the patient experienced halos and glare.The lens was explanted in a secondary procedure with another lens.Additional information was requested.
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).
Additional Manufacturer Narrative
The lens was returned in a water like liquid inside a plastic specimen cup.The lens was cleaned with klrp for further evaluation.The lens was allowed to dry.The optic had a scuff marks and cracks on the anterior and posterior sides of the lens in a shape of an instrument used to grasp the lens.A power and resolution inspection was conducted by an engineering tech and the lens met specification for a company lens.Qualified associated products were indicated.The root cause cannot be determined for the reported complaint.A power and resolution inspection was conducted and the lens met specification for a company lens.Information was provided that the multifocal toric company lens model was exchanged for a non-company monofocal lens.Due to the exchange of a multifocal toric lens to a monofocal lens may suggest that the replacement lens model 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).
Event or Problem Description
Additional information was received, stating the patient experienced starbursts.There was no patient harm.No medical or surgical intervention was required as a result of this event.Patient was not hospitalized.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).

• 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: 15095002
• Report Number: 1119421-2022-01620
• Device Sequence Number: 14751731
• Product Code: MFK
• UDI-Device Identifier: 00380652418706
• UDI-Public: 00380652418706
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/23/2022

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: 07/05/2026
• Device Model Number: TFAT30
• Device Catalogue Number: TFAT30.200
• Device Lot Number: 15220644
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2022
• Supplement Date Received by Manufacturer: 08/02/2022; 09/07/2022
• Initial Report FDA Received Date: 07/25/2022
• Supplement Report FDA Received Date: 08/22/2022; 09/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2021
• 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 IOL CARTRIDGE D; MONARCH III IOL INJECTOR; PROVISC
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male