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

Model Number	TFNT00
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample device was not returned for analysis.Complaint history and product history records were reviewed and the documentation indicated the product met release criteria.There have been no other complaints reported in the lot number.The root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A nurse reported during the intraocular lens implantation a scratch was found at the center of the lens so the lens was not used.Additional information has been requested.
Additional Manufacturer Narrative
The lens was returned positioned incorrectly in the lens case.Solution was dried on the lens.Both haptics are bent in the gusset and distal area.The optic was pressed against the posts and leaning down into the well area of the lens case.The optic has a large scratch on the anterior side of the lens near the central optic zone.The optic has additional small scratches and scuff marks on the anterior and posterior sides in the shape of an instrument used to grasp the lens was observed.The returned sample matches the attached photo.It is unknown if qualified products were used.Reported scratch was observed.All lenses are 100% inspected for cosmetic attributes and the damage exhibited by the returned complaint sample would not have met company release criteria.Based on our observation, and the review of manufacturing records, 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.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Two photos were provided of the lens being held by tweezers.There appears to be a scratch/mark near the central portion of the optic.And clinical solution appears to be present on the lens.Associated products were not provided.It is unknown, if qualified products were used.Based on our observation of the attached photos, the lens is scratched and clinical solution appears to be present on the lens.It is difficult to make a final determination without evaluation of the physical sample.The root cause cannot be determined, based on available information.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: 14207760
• Report Number: 1119421-2022-00851
• Device Sequence Number: 19942293
• Product Code: MFK
• UDI-Device Identifier: 00380652392785
• UDI-Public: 00380652392785
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: TFNT00
• Device Catalogue Number: TFNT00.125
• Device Lot Number: 12683791
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/31/2022
• Supplement Date Received by Manufacturer: 06/23/2022; 07/29/2022
• Initial Report FDA Received Date: 04/26/2022
• Supplement Report FDA Received Date: 07/19/2022; 08/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2019
• 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
• Patient Sex: Unknown