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

Model Number	CNWTT4
Medical Device Problem Code	Optical Decentration (1360)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	05/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A non-healthcare professional reported that following an intraocular lens (iol) implant procedure, the patient experienced blurry distance vision left eye, reading and intermediate, intra ocular lens was decentered.Clinical reason for explant poor intra ocular lens support.The iol was exchanged with non company intraocular lens 1 months 5days following the initial implant procedure.Additional information has been requested.
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).
Additional Manufacturer Narrative
Additional information was provided in d.9., h.3., h.6.And h.11.The product was returned for analysis.The reported complaint cannot be confirmed from the returned sample.Intraocular lens (iol) returned in two pieces wrapped in medical gauze, in an envelope labelled with sn 25387758109.Solution is dried on the iol.One haptic is adhered to the optic surface in a folded position, the other haptic is intact.The edge of one optic segments is nicked/chipped-rejectable.Loose fibers are present on both segments of the iol.It is stated in the file that in the surgeon¿s opinion the product did not cause or contribute to the event.In the surgeon¿s opinion it was poor iol support that caused the event.The root cause for the reported complaint appears to be a coincidental event that was unrelated to the product as user facility reported that according to the surgeon, the iol did not cause the event.In the surgeon¿s opinion it was poor iol support that caused the event.Based on this information, the product did not cause/contribute to the event.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 TORIC TRIFOCAL HYDROPHOBIC IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 21240832
• Report Number: 9612169-2025-00129
• Device Sequence Number: 19748910
• Product Code: MJP
• UDI-Device Identifier: 00380652469036
• UDI-Public: (01)00380652469036(17)260402(11)220404(10)25387758
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Report Date (Section B): 04/17/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/02/2026
• Device Model Number: CNWTT4
• Device Catalogue Number: CNWTT4.185
• Device Lot Number: 25387758
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/02/2025
• Supplement Date Received by Manufacturer: 03/19/2025
• Initial Report FDA Received Date: 01/27/2025
• Supplement Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2022
• 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: MONARCH III IOL INJECTOR; MONARCH III IOL CARTRIDGE D; PROVISC OVD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female