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

Model Number	CNWTT0
Medical Device Problem Codes	Break (1069); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/27/2023
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.The complainant indicates the use of non-company ophthalmic viscosurgical devices (ovds) and non-company injector which are not qualified for use with the associated iol model.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, leading haptic was found missing after implantation.It was confirmed that the leading haptic remained in the cartridge.The surgery was completed after replacing the product with another one.Additional information has been requested.
Additional Manufacturer Narrative
The product was returned for analysis and the reported complaint was observed.Iol returned wrapped in surgical gauze.Solution is dried on both surfaces of the optic and one haptic.One haptic is broken/torn and is returned inside a cartridge, the other haptic has fibers.The optic has a piece missing and is cracked/fractured and scratched/marked-rejectable with loose fibers & particulate.Haptic in cartridge sent to investigation site for further evaluation the used cartridge was received.Viscoelastic was observed in the cartridge.A broken haptic was observed in the cartridge nozzle.The cartridge has evidence of placement into a handpiece.No cartridge damage observed.The cartridge was cleaned for further evaluation.The haptic was removed during cleaning.Top coat dye stain testing was conducted with acceptable results.The complainant indicates the use of non company ovd and non company injector which are not qualified for use with the associated iol model.The root cause may be related to failure to follow instructions for use (ifu), as the surgeon states the use of non-qualified injector and ovd combination.The use of an unqualified combination may cause damage to the iol and potential complications during the implantation process.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: 17611170
• Report Number: 9612169-2023-00612
• Device Sequence Number: 20687999
• Product Code: MFK
• UDI-Device Identifier: 00380652407953
• UDI-Public: 00380652407953
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2023

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: 05/23/2026
• Device Model Number: CNWTT0
• Device Catalogue Number: CNWTT0.115
• Device Lot Number: 25420008
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/15/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/27/2023
• Supplement Date Received by Manufacturer: 10/24/2023
• Initial Report FDA Received Date: 08/24/2023
• Supplement Report FDA Received Date: 11/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2022
• 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: ASICO INJECTOR; MONARCH CARTRIDGE D; OPEGAN-HI
• Patient Sex: Unknown