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

Model Number	SY60WF
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	Corneal Edema (1791)
Date of Event	12/09/2025
Type of Reportable Event	Malfunction
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 pharmacist reported that during cataract surgery with intraocular lens (iol) implant procedure, the surgeon observed three distinct marks located centrally on the iol, directly within the visual axis.It was stated that these marks appeared consistent with potential pressure from the injector, in addition to that the implant was found to be extremely fragile, tearing very easily during the manipulation and during subsequent attempts of explantation.Hence, the iol was removed and replaced with an another iol.Procedure was completed on the same day.Additional information recieved and stated that diffuse corneal edema was noted followed by the intraoperative explantation of the iol.On the postoperative day 7 the visual activity was recorded as "counts fingers".The defective implant was explanted and explantation was challenging as the implant tore into small fragments, preventing removal in a single piece despite attempts to section it intracamerally.
Additional Manufacturer Narrative
Additional information was provided in d.4.The manufacturer internal reference number is: (b)(4).

• 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: 23958182
• Report Number: 1119421-2026-00032
• Device Sequence Number: 20236537
• Product Code: HQL
• UDI-Device Identifier: 00380652251525
• UDI-Public: (01)00380652251525(17)280410(11)240412(10)15840387
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: SY60WF
• Device Catalogue Number: SY60WF.220
• Device Lot Number: 15840387
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/16/2025
• Supplement Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 01/30/2026
• Date Device Manufactured: 04/12/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DUOVISC VISCOELASTIC SYSTEM
• Patient Age: 82 YR
• Patient Sex: Female