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

Model Number	CNWTT0
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.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 complainant indicates the use of opelead as a viscoelastic, which is not qualified for use with company model, this is not a qualified company product combination.Photo provided shows what appears to be a mark/scratch on the optic area of the lens.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A customer reported during the intraocular lens implantation something like a scratch was confirmed on the lens optical part after implanting.The doctor does not think it will affect patient's eyesight, so the lens replacement is not scheduled.The lens remains implanted.Additional information has been requested.
Additional Manufacturer Narrative
Video provided does not show lens preparation or ophthalmic viscoelastic device (ovd) fill.When the nozzle comes into view the iol is already advancing through the nozzle tip.The lens appears to be in a correct position for the advancement.The plunger is at the trailing optic edge and both haptics are folded onto the optic.The lens was advanced intermittently with the plunger from the nozzle.Instrumentation is used to unfold and position the iol.A rectangular scratch/foreign material can be seen near the edge of the optic.Unsuccessful attempts are made to remove the object with surgical instrumentation.The complainant indicated the use of company injector, which is not qualified for use with company lens model.Based on our observation of the attached video, a rectangular scratch/foreign material can be seen near the edge of the optic.A definitive determination of observed condition cannot be made without the evaluation of the physical product.A final root cause cannot be determined based on available information.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: 16500761
• Report Number: 9612169-2023-00194
• Device Sequence Number: 6297911
• Product Code: MFK
• UDI-Device Identifier: 00380652407991
• UDI-Public: 00380652407991
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2023

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: 01/19/2025
• Device Model Number: CNWTT0
• Device Catalogue Number: CNWTT0.135
• Device Lot Number: 25263579
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2023
• Supplement Date Received by Manufacturer: 04/25/2023
• Initial Report FDA Received Date: 03/08/2023
• Supplement Report FDA Received Date: 05/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2021
• 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: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; OVD: OPELEAD
• Patient Sex: Unknown