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

Model Number	TFNT00
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/20/2021
Type of Reportable Event	Serious Injury
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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported that, during cataract surgery with intraocular lens (iol) implant procedure, haptics got ruptured inside the cartridge.A replacement of the lens was made.Additional information was received by consumer that, the implant was removed.
Additional Manufacturer Narrative
The product was not returned for evaluation.Three photos were provided.The cartridge model is not compatible with the handpiece.One photo shows the cartridge seated incorrectly in a non-qualified handpiece.One haptic is visible under the handpiece plunger at the cartridge tip.The other two photos are after the cartridge was removed from the handpiece.One broken haptic is visible near the loading area and one broken haptic is observed in the cartridge tip.Based on the provided photos the cause of the broken haptics was related to a failure to follow the instructions for use (ifu).The cartridge model and handpiece used are not a compatible combination.The cartridge will not seat properly in the handpiece as observed in the provided photo.The misalignment of the non-compatible cartridge would have caused the plunger and lens to advance incorrectly causing damage to the lens.Per the ifu: the company cartridges are qualified for use with compatible company handpieces for the surgical implantation of company qualified foldable iols.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 manufacturer internal reference number is: 2021-67107.

• 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: 12846904
• Report Number: 1119421-2021-02174
• Device Sequence Number: 4353077
• Product Code: MFK
• UDI-Device Identifier: 00380652357852
• UDI-Public: 00380652357852
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/11/2025
• Device Model Number: TFNT00
• Device Catalogue Number: TFNT00.260
• Device Lot Number: 15111643
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2021
• Supplement Date Received by Manufacturer: 01/11/2022
• Initial Report FDA Received Date: 11/19/2021
• Supplement Report FDA Received Date: 02/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DISCOVISC; MONARCH II IOL INJECTOR; MONARCH III IOL CARTRIDGE D
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown