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

Model Number	TFNT30
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/04/2022
Type of Reportable Event	Malfunction
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.(b)(4).
Event or Problem Description
A physician reported that during cataract surgery with intraocular lens implant procedure, lens found to have foreign body attached to it.The surgeon inspected both sides of the lenses under the scope before loading into cartridge but then foreign material appeared in eye.The foreign material was removed from the eye with irrigation and aspiration (i/a).It was difficult to get off and the surgeon felt like it was stuck to the back of the lens.
Additional Manufacturer Narrative
The lens remains implanted.The foreign material was not returned.A video was provided.The lens/cartridge preparation and lens delivery were not shown.The video started with the lens already implanted.The lens was a multifocal toric single-piece lens.A possible mark or material was faintly visible.The lens position did not allow for a better view.The camera shifted off the eye.When the view was placed back on the eye, no foreign material was observed.The camera partially shifted off the eye again.Only a corner of the lens was visible as it was aligned.The lens remained implanted.Product history records were reviewed and documentation indicated the product met release criteria.A qualified cartridge was indicated.The handpiece and viscoelastic used were not provided.It is unknown if qualified products were used.The product investigation could not identify a root cause for the reported complaint.The nature and origin of the foreign material cannot be determined from the video.No determination can be made without physical evaluation of the complaint sample.It is unknown if a qualified handpiece and viscoelastic were used.Per the instruction for use (ifu): company foldable iols are qualified for use with an company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The use of an unqualified combination may cause damage to the iol and potential complications during the implantation process.The ifu also instructs to completely fill the cartridge with ovd immediately prior to loading and delivery of the lens.Do not attempt to load the lens without adequate ovd in the device.Not adequately filling the device with viscoelastic will result in inadequate coverage of lens and the lens fold path with ovd, which may result in damage.There are no other complaints in this lot.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: 15321927
• Report Number: 1119421-2022-01877
• Device Sequence Number: 20156849
• Product Code: MFK
• UDI-Device Identifier: 00380652390033
• UDI-Public: 00380652390033
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2022

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: 02/29/2024
• Device Model Number: TFNT30
• Device Catalogue Number: TFNT30.230
• Device Lot Number: 12701079
• 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: 08/04/2022
• Supplement Date Received by Manufacturer: 11/09/2022
• Initial Report FDA Received Date: 08/30/2022
• Supplement Report FDA Received Date: 12/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MONARCH CARTRIDGE D
• Patient Sex: Unknown