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

Model Number	CCWTT3
Medical Device Problem Codes	Use of Incorrect Control/Treatment Settings (1126); Defective Device (2588)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); Blurred Vision (2137); Visual Impairment (2138)
Date of Event	09/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A product 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 manufacturer internal reference number is: (b)(4).
Event or Problem Description
A facility representative reported that following intraocular lens (iol) implantation, patient's distance vision not good, near was ok.The lens was exchanged for an unknown advanced technology intraocular lens after the initial implant procedure.Clinical reason iol malfunction.Additional information received stating that distance vision was blurry and had a hard time watching the tv.After initial implant procedure visual acuity was 20/150 and intraocular pressure (iop) was 22 mmhg.The post-operative measurements after lens exchange visual acuity was 20/40 and iop was 9 mmhg.In the surgeon¿s opinion product did not contribute to the event.In the surgeon¿s opinion high myopic surprise caused the event.
Additional Manufacturer Narrative
In initial mdr the product code a0203 was submitted.It should have been a2302 in the original mdr.The product was not returned.All product and batch history records are quality reviewed prior to product release.The account indicated the use of qualified associated products.An intraocular lens (iol) exchange for a difference equal to or greater than two diopters, indicates the event is most likely related to a calculation error.Information was provided that, in the surgeon's opinion the product did not cause or contribute to the event.In the surgeon's opinion, the event was related to high myopic surprise.Based on the information provided, the event does not appear to be related to the product.Each lens is subjected to a 100 percent assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.Additional information was provided that the company (1.50 cylinder), 18.0 diopter (add power +2.2/+3.2) lens was replaced with a company (1.50 cylinder), 14.0 diopter (add power +2.2/+3.2) lens.No additional information has been provided at this time.File will be reopened when new information or the product is received.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6.And h.11.The product was not returned.Complaint history and product history records were reviewed, and documentation indicated the product met release criteria.The account indicated the use of qualified associated products.An intraocular lens (iol) exchange for a difference equal to or greater than two diopters, indicates the event is most likely related to a calculation error.Based on the information provided, the event does not appear to be related to the product.Each lens is subjected to a 100 percent 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.Information was provided that the company (1.50 cylinder), 18.0 diopter (add power +2.2/+3.2) lens was replaced with a company (1.50cylinder), 14.0 diopter (add power +2.2/+3.2) lens.An exchange for the same lens model with a 4.0 difference in diopter would support this was a calculation issue.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON PANOPTIX TORIC TRIFOCAL UV ABSORBING 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: 20894304
• Report Number: 1119421-2024-02430
• Device Sequence Number: 7921214
• Product Code: MJP
• UDI-Device Identifier: 00380652457347
• UDI-Public: (01)00380652457347(17)270430(11)230502(10)15640662
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: CCWTT3
• Device Catalogue Number: CCWTT3.180
• Device Lot Number: 15640662
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/12/2024
• Supplement Date Received by Manufacturer: 01/08/2025; 02/11/2025
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 01/31/2025; 03/07/2025
• Date Device Manufactured: 05/02/2023
• 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: CLAREON MONARCH IV , INJECTOR; CLAREON PANOPTIX TORIC TRIFOCAL UV ABSORBING IOL; DUOVISC; MONARCH II LOADING FORCEPS; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 83 YR
• Patient Sex: Male