MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON CLAREON PANOPTIX TRIFOCAL UV ABSORBING INTRAOCULAR LENS; LENS, MULTIFOCAL INTRAOCULAR

Model Number	CCWTT0
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A materials manager reported that during a cataract extraction with an intraocular lens (iol) implant procedure, they found smudged lens and it was removed by irrigation and aspiration.Additional information was requested, but further no information was available.
Additional Manufacturer Narrative
The lens was not returned.Product history records were reviewed and documentation indicated the product met release criteria.A qualified cartridge and handpiece were indicated.The viscoelastic indicated is not qualified.The product investigation could not identify a root cause for the reported complaint.No determination can be made without physical evaluation of the complaint sample.A non-qualified viscoelastic was indicated.Per the instructions for use (ifu): the company intraocular lens delivery system is for implantation of qualified company foldable intraocular lenses.No unqualified lenses should be used with the company intraocular lens delivery system.The company cartridges are qualified for use with compatible company handpieces for the surgical implantation of company qualified foldable intraocular lenses.Company foldable intraocular lenses 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 intraocular lens and potential complications during the implantation process.Follow the section regarding directions for use for information on the maximum allowed time for the intraocular lens to stay in the folded condition.Failure to adhere to manufacturer¿s recommendations may result in intraocular lens damage.Note: during lens loading and insertion, do not allow the company uv absorbing intraocular lens to remain in a folded condition within the selected intraocular lens delivery system for more than 3 minutes prior to completing insertion into the capsular bag.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON PANOPTIX TRIFOCAL UV ABSORBING INTRAOCULAR LENS
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• 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: 15681165
• Report Number: 1119421-2022-02278
• Device Sequence Number: 12346464
• Product Code: MFK
• UDI-Device Identifier: 00380652413749
• UDI-Public: 00380652413749
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/27/2022

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: 12/19/2024
• Device Model Number: CCWTT0
• Device Catalogue Number: CCWTT0.250
• Device Lot Number: 15241362
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/29/2022
• Initial Report FDA Received Date: 10/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2021
• 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: AMVISC; CLAREON MONARCH IV IOL, INJECTOR; MONARCH III IOL, CARTRIDGE D
• Patient Sex: Female