MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON CLAREON TORIC IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	CNW0T3
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A non-health care professional reported that during an intraocular lens (iol) implant procedure, the toric lens was implanted but removed.The embossed dots on the lens for the alignment purposes were not correct on the lens or not in the correct location and seems a manufacturing issue.There was patient contact.Additional information has been requested.
Additional Manufacturer Narrative
The intra ocular lens (iol) was returned in the lens case.Viscoelastic was observed on the lens.The lens had been cut into two pieces, returned adhered to each other.The lens portions were cleaned with klrp (klotho-related protein) to separate.The toric axis marks were misaligned/shifted.Product history records were reviewed and documentation indicated the product met release criteria.The root cause was determined to be related to the milling process.Auto-milling equipment did not properly place the wafer on mill post to ensure correct location of axis marks in relation to the mill path.This was determined to be a cosmetic issue.The toric axis is aligned with the toric axis marks.This is set by the mold.Each lens is subjected to a 100% assessment of the power (spherical and cylinder) and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.Toric lens models have a 100% inspection at plainview to verify the axis mark alignments fall within the position bands per an approved template.The lens would not have met release criteria for the axis mark alignment.Improvements to the planview procedure to align requirements for inspection order and axis marks alignment with the templates was completed on (b)(6)2023.This lens was manufactured before the procedure updates.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Correction information was provided in h.6.- component code updated.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON TORIC IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 19655876
• Report Number: 1119421-2024-01244
• Device Sequence Number: 6822795
• Product Code: MJP
• UDI-Device Identifier: 00380652409735
• UDI-Public: (01)00380652409735(17)270103(11)230105(10)15557852(21)15557852051
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2024

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 Model Number: CNW0T3
• Device Lot Number: 15557852
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/04/2024
• Supplement Date Received by Manufacturer: 07/15/2024
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 08/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2023
• 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 CARTRIDGE D; MONARCH INJECTOR; MONARCH II LOADING FORCEPS; VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE
• Patient Sex: Unknown