MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON PANOPTIX TRIFOCAL HYDROPHOBIC INTRAOCULAR LENS; LENS, MULTIFOCAL INTRAOCULAR

Model Number	CNWTT0
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2023
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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported that, during the cataract surgery with intraocular lens (iol) implant procedure, noticed foreign material adhered to the iol optics after iol insertion.The surgery was completed after replacing the product with another lens.Team has looked at it together in the surgery room, but could not observe it.The doctor said that it was transparent linear material and that it would be visible under an electron microscope.Additional information has been requested.
Event or Problem Description
Additional information has been requested and received stating there was no health problem to the patient.
Additional Manufacturer Narrative
Iol received in non company pouch along with surgical fabric.Solution is dried on both surfaces of the optic and one haptic, the iol is adhered to the fabric.One haptic is adhered to the side of the optic with solution, the other haptic is intact.The optic is cut in two and has numerous fibers and particulate adhered.Sent to ftw lab for further evaluation.The "transparent linear material" was isolated and analyzed (see lab results attached).Comparison to a library of spectra finds the best match to be wypall fibers (natural fibers).The presence of foreign material was confirmed.Based on the spectral comparison results, the fibre is wypall fibre (natural fibers).The origin of the material could not be determined.No wypall paper is used in company environmental controlled production areas.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON PANOPTIX TRIFOCAL HYDROPHOBIC INTRAOCULAR LENS
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 16744413
• Report Number: 9612169-2023-00291
• Device Sequence Number: 20467875
• Product Code: MFK
• UDI-Device Identifier: 00380652407908
• UDI-Public: 00380652407908
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2023

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: 05/17/2026
• Device Model Number: CNWTT0
• Device Catalogue Number: CNWTT0.090
• Device Lot Number: 25415236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/19/2023
• Supplement Date Received by Manufacturer: 06/19/2023
• Initial Report FDA Received Date: 04/14/2023
• Supplement Report FDA Received Date: 07/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2022
• 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: CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR; DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D
• Patient Sex: Unknown