MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON VIVITY TORIC EXTENDED VISION UV ABSORBING IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	CCWET3
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	09/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility representative reported that following an intraocular lens (iol) implant procedure, patient dis-satisfied with vision and vision off.The lens was then exchanged with company iol different model, following the initial implant procedure.Clinical reason for explantation was malpostion iol and incorrect power.Suture of lens or incision or incision enlargement needed.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 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 three segments in sealed noncompany pouch.Solution is dried on the iol.One haptic is broken/torn and is returned, the other haptic is intact.The optic scratched/marked rejectable.Additional information: the reporter stated the company14 d lens was replaced with a company 15 d lens.The surgeon states that in his opinion the iol did not contribute to 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.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 VIVITY TORIC EXTENDED VISION UV ABSORBING 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: 20742388
• Report Number: 9612169-2024-01206
• Device Sequence Number: 15606827
• Product Code: MJP
• UDI-Device Identifier: 00380652455169
• UDI-Public: (01)00380652455169(17)250227(11)211006(10)25281836
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 02/10/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/27/2025
• Device Model Number: CCWET3
• Device Catalogue Number: CCWET3.140
• Device Lot Number: 25281836
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2024
• Supplement Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 11/21/2024
• Supplement Report FDA Received Date: 02/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2021
• 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: CLAREON TORIC UV ABSORBING IOL; DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE; MONARCH II LOADING FORCEPS; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; ORA SYSTEM WITH VERIFEYE MESSAGING
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female