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); Iritis (1940); Blurred Vision (2137); Eye Pain (4467)
Date of Event	05/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned.A product history record review and a non-conformance review of the reported lot number was conducted.No deviations were identified and all corresponding production release specifications defined in the device master record were met.The root cause for the reported infection cannot be determined.All iols (intra ocular lenses) are terminally sterilized with 100 percent ethylene oxide sterilization.Company 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.The customer reports the suspect product as unknown.The manufacturer internal reference number is: (b)(4).H10 reflects all related report numbers associated with this product event that have been submitted at this time.
Event or Problem Description
A customer reported that a male patient was diagnosed with endophthalmitis and presented with light perception only (very limited vision) with visual acuity changed to 20/50, pain, conjunctivitis, vitritis and hypopyon in the right eye along with the presence of aqueous cell and aqueous fibrin post fourteen days from uncomplicated phacoemulsification surgery with iol procedure.Pre-operative medications were given to perform surgery aseptically and wound integrity was found to be intact after performing seidel test post completion of surgery.A culture was performed with no growth.Anterior chamber tap was performed along with intravitreal antibiotics injection but it was not effective.Post operative steroid, antibiotic and non-steroidal anti-inflammatory drugs (nsaid) were prescribed and the patient is under monitoring.Current status of the patient is symptoms continuing.This complaint is pertaining to one of the two patients reported with post operative infections from the facility.

• 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: 22688635
• Report Number: 1119421-2025-02121
• Device Sequence Number: 12261177
• Product Code: HQL
• UDI-Device Identifier: 00380652251488
• UDI-Public: (01)00380652251488(17)290113(11)250115(10)15977623
• 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
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/01/2025

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.200
• Device Lot Number: 15977623
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 08/01/2025
• Date Device Manufactured: 01/15/2025
• 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: AMOXIFLOXIN DROPS TID; BETADINE MD5093940; BSS IRRIGATING SOLUTION; CENTURION VISION SYSTEM; CUSTOM-PAK SURGICAL PROCEDURE; KETOROLAC DROPS TID; OZIL TORSIONAL HANDPIECE; POVIDONE IODINE; PREDNISILONE DROPS TID; PROVISC; STERILE WATER R5000-01; TETRACAINE: 00370069601013; VISCOAT
• Outcome Attributed to Adverse Event: Other
• Patient Age: 79 YR
• Patient Sex: Male