MAUDE Adverse Event Report: Alcon Laboratories Ireland Ltd. Clareon IOL; Intraocular Lens

Model Number	SY60WF
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	07/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A healthcare professional reported that, following intraocular lens implantation surgery, the lens did not achieve the intended refractive target due to a power/diopter-related issue.Hence the lens implanted in the patient's eye was removed to change the lens power and replaced with unspecified lens in a secondary procedure.Additional information has been requested but is not available at the time of this report.There are two medical reports associated with same patient.This file belongs to the left eye.
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) h.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• Brand Name: Clareon IOL
• Common Device Name: Intraocular Lens
• 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 ; +1(800)757-9780
• MDR Report Key: 50019375
• Report Number: 9612169-2026-01705
• Device Sequence Number: 10603783
• Product Code: HQL
• UDI-Device Identifier: 00380652251501
• UDI-Public: (01)00380652251501(17)281218(11)241220(10)25975822
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/24/2026

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: SY60WF
• Device Lot Number: 25975822
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/02/2026
• Initial Report FDA Received Date: 07/27/2026
• Date Device Manufactured: 12/20/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown