MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON CLAREON ASPHERIC HYDROPHOBIC ACRYLIC IOL; INTRAOCULAR LENS

Model Number	SY60WF
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Conjunctivitis (1784); Endophthalmitis (1835); Hypopyon (1913); Inflammation (1932); Blurred Vision (2137)
Date of Event	06/18/2025
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 nurse reported that following an intraocular lens (iol) implant procedure, the patient had surgery on (b)(6) 2025, at one day post operation there were no complaints.The following morning the patient reported pain with decreased vision in the right eye.With 3+ conjunctival inflammation, 2+ cell, aqueous fibrin and hypopyon diagnosed as endophthalmitis.The patient had intravitreal injection and was referred to a retinal specialist.No cultures was taken.
Additional Manufacturer Narrative
Additional information has been provided in b.2., b.5., b.6., h.3.And h.11.The product was not returned.A device history record review and a non-conformance review of the reported lot number was conducted.The deviation review did not reveal any potential contributing factors to the reported complaint and all corresponding production release specifications defined in the device master record were met.The product investigation could not identify a root cause for the reported complaint.The product was not returned.All iols (intraocular lens) are terminally sterilized with 100% ethylene oxide sterilization.Company hwv uses an overkill sterilization approach, which greatly exceeds the minimum requirements for sterility.Critical parameters for sterilization cycles are recorded and retained for every sterilization load to demonstrate that the acceptance criteria for the sterilization process are met.Information was provided that the surgeon does not feel any company product caused or contributed to the event.The patient had intravitreal injection and was referred to a retinal specialist.The patient is doing well.They were released from retina and last seen on 13-aug-2025 with orders to return in one year.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received by stating, the endophthalmitis in the right eye was improving.It was still a little hazy, but it was getting better.His vision had improved since his last visit.The surgeon had made some changes to his current glasses prescription to improve his overall acuity.The iop (intraocular pressure) was in a good range in both eyes.

• Brand Name: CLAREON ASPHERIC HYDROPHOBIC ACRYLIC IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 22493613
• Report Number: 1119421-2025-01920
• Device Sequence Number: 4272134
• Product Code: HQL
• UDI-Device Identifier: 00380652251372
• UDI-Public: (01)00380652251372(17)290224(11)250226(10)15998779
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2025

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: SY60WF
• Device Catalogue Number: SY60WF.145
• Device Lot Number: 15998779
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/19/2025
• Supplement Date Received by Manufacturer: 08/27/2025
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 09/19/2025
• Date Device Manufactured: 02/26/2025
• 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: IRIS EXPANDER.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 88 YR
• Patient Sex: Male