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

Model Number	TFNT40
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2021
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 documentation indicated the product met release criteria.Root cause has not been identified.There have been no other complaints reported in the lot number. additional information has been requested.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported that during intraocular lens (iol) implantation, lens came out from the injector broken.There was no patient injury.Additional information was requested.
Additional Manufacturer Narrative
Corrected information was provided in d.10 which was not added in the initial mdr submitted.The product was not returned.A photo was provided of the lens on the outside of the cartridge, near the loading area.The lens was damaged and viscoelastic was observed.The use of a non-qualified cartridge was indicated.The customer indicated the use of an unspecified injector and an unspecified viscoelastic.It is unknown if qualified products were used.The alleged, 26.0 diopter lens is only qualified for use in the other company cartridges.The alleged lens model is only qualified for the used cartridge for the diopter range of 6.0 to 25.0.Based on our observation of the attached photo, the lens is damaged.The root cause may be related to a failure to follow the dfu.The customer indicated the use of a non-qualified lens/cartridge combination.The use of non-qualified combinations may lead to delivery issues and/or damage to the lens or the cartridge.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
• MDR Report Key: 11848761
• Report Number: 1119421-2021-01062
• Device Sequence Number: 17091953
• Product Code: MFK
• UDI-Device Identifier: 00380652390644
• UDI-Public: 00380652390644
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2021

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: 07/31/2022
• Device Model Number: TFNT40
• Device Catalogue Number: TFNT40.260
• Device Lot Number: 12560977
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/28/2021
• Supplement Date Received by Manufacturer: 07/04/2021
• Initial Report FDA Received Date: 05/19/2021
• Supplement Report FDA Received Date: 07/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MONARCH CARTRIDGE D; UNKNOWN INJECTOR; UNKNOWN INJECTOR