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

Model Number	TFNT00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	07/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A nurse reported that during implantation of intraocular lens (iol), the haptic was found detached.The lens was explanted from the extended corner by enlarging the incision to 2.5mm.The surgery was completed by replacing with the same model and diopter lens.There were no complications.
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.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The lens was returned positioned incorrectly in the lens case in the carton.Viscoelastic was dried on the lens.One haptic was bent in the gusset area.This haptic was also torn and split in the gusset (still attached).This may have been interpreted as the complaint.This haptic also has a line of a deep scrape mark across the anterior surface of the haptic/optic junction.The anterior and the posterior optic surfaces have multiple areas that are cracked and split.Product history records were reviewed and the documentation indicated the product met release criteria.The account indicated the use of a qualified associated cartridge and viscoelastic.The handpiece information was not provided.It is unknown if a qualified product was used.One haptic was torn and split, but still attached.This may have been interpreted as the complaint.All lenses are 100% inspected for cosmetic attributes and the damage exhibited by the returned complaint sample would not have met company's 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).

• 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: 17538806
• Report Number: 1119421-2023-01442
• Device Sequence Number: 17739540
• Product Code: MFK
• UDI-Device Identifier: 00380652357821
• UDI-Public: 00380652357821
• Combination Product (Y/N): N
• Initial Reporter Country: LO
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: TFNT00
• Device Catalogue Number: TFNT00.245
• Device Lot Number: 15566862
• 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: 07/20/2023
• Supplement Date Received by Manufacturer: 09/14/2023
• Initial Report FDA Received Date: 08/14/2023
• Supplement Report FDA Received Date: 10/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2023
• 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 DELIVERY SYSTEM, CARTRIDGE D.; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown