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

Model Number	TFNT60
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A healthcare professional reported that during intraocular lens implantation procedure, before inserting in the cartridge detached haptic was noted.The patient was left aphakic.Additional information was received stating the surgery was completed a week after.
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6.And h.11.The lens was returned positioned incorrectly (posterior surface up) in a lens case in the opened, folded peel pouch placed inside the lens carton.Solution was dried on the lens.One haptic was broken in the gusset area.The broken haptic was not returned.The other haptic was broken in the distal area.The broken distal haptic portion was returned bent in the distal tip area and adhered to the lens in dried solution.The optic was torn and split from the side edge travelling toward the toric axis marks.The optic edge was scraped on the posterior.Additional cracked and gouged damage was observed on the posterior surface near the optic edge.The photos show the broken haptic and optic damage.One haptic appeared bent against a post.Upon return, this haptic was broken due to position in the lens case.Product history records were reviewed and the documentation indicated the product met release criteria.The viscoelastic present on the returned lens is unknown.The reported broken haptic damage was observed in the photos and during the product evaluation.The product investigation could not identify a root cause for the damage.The observed lens damage is similar in appearance to handling related damage.All lenses are 100 percent inspected for cosmetic attributes and the damage exhibited by the returned complaint sample would not have met alcon¿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, we are unable to verify that the damage was present when opened.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ PANOPTIX TORIC 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: 19497007
• Report Number: 1119421-2024-01094
• Device Sequence Number: 20791795
• Product Code: MFK
• UDI-Device Identifier: 00380652391849
• UDI-Public: (01)00380652391849(17)250812(11)200813(10)15091490(21)15091490094
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2024

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 Expiration Date: 08/12/2025
• Device Model Number: TFNT60
• Device Catalogue Number: TFNT60.320
• Device Lot Number: 15091490
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2024
• Supplement Date Received by Manufacturer: 07/09/2024
• Initial Report FDA Received Date: 06/10/2024
• Supplement Report FDA Received Date: 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/13/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown