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); Corneal Edema (1791); Endophthalmitis (1835); Intraocular Pressure Increased (1937); Iritis (1940); Red Eye(s) (2038); Blurred Vision (2137); Eye Infections (4466); Eye Pain (4467)
Date of Event	08/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A non-healthcare professional reported that following the intraocular lens (iol) implant procedure, the patient experienced endophthalmitis.Additional information stated that cataract surgery was performed on (b)(6) 2025 in the left eye.The procedure lasted 7 minutes, had no complications, no sutures, and wound integrity was intact.For prophylaxis, a postoperative subconjunctival antibiotic injection, steroid, and nonsteroidal anti-inflammatory drug were given.The patient experienced pain, blurry vision, redness, and swelling.A diagnosis of infectious endophthalmitis was made, with vitreous inflammation 3+, conjunctival inflammation 2+, aqueous cells 3+, and aqueous fibrin present.And culture was not done.The onset was less than 14 days postoperatively, on (b)(6) 2025.The event resulted in clinically significant visual changes.The surgeon was unsure what caused or contributed to the event.The other potential contributing factors mentioned was retro performed in pre-operation.On (b)(6) 2025, the patient received intravitreal antibiotic treatment and was referred to a retinal specialist.It was unknown if the intervention was effective.The outcome of the event was unknown.
Additional Manufacturer Narrative
The product was not returned for analysis.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.Root cause has not been identified.All iols are terminally sterilized with 100% 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 manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Corrected information provided in d.10., e.4., h.6.And h.11.Fda patient codes of e0820 and e0828 have been added.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 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: 23098170
• Report Number: 1119421-2025-02529
• Device Sequence Number: 15624820
• Product Code: HQL
• UDI-Device Identifier: 00380652251594
• UDI-Public: (01)00380652251594(17)290114(11)250116(10)15977896
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2025

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.255
• Device Lot Number: 15977896
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/26/2025
• Supplement Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 11/05/2025
• Date Device Manufactured: 01/16/2025
• 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: 3CC 2% LIDO.; ALCAINE.; BROMITE.; CEFTAZIDIME.; CEFUROXIME 1MG.; CENTURION SURGICAL PROCEDURE PAK.; CENTURION VISION SYSTEM.; CENTURION VISION SYSTEM.; COMBIGAN BID.; CYLCOPENTOLATE TID,; DIAMOX 500 MG BID.; DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE.; HAND PIECE.; INTREPID BIMANUAL POLYMER DISPOSABLE I/A SET.; LIDO JELLY.; N&M.; PF Q H.; POVIDONE IONDINE 5%,; RETRO BLOCK.; VANCOMYCIN.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 25 YR
• Patient Sex: Female