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

Model Number	SY60WF
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/04/2025
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 non-healthcare professional reported that during an intraocular lens (iol) implant procedure, the lens was defective during initial procedure.Additional information was received that the anterior chamber and capsular bag were filled with viscoelastic and a 23.0 diopter lens was inserted into the lens.Upon insertion, the trailing haptic was noted to be sheared off from the optic, therefore the decision was made to explant the lens.Additional viscoelastic was placed into the capsular bag and in the anterior chamber.The lens was removed from the eye using the "twist and out" technique using noncompany forceps and noncompany spatula to protect the endothelium.A new same company same diopter lens was inserted into the posterior chamber capsular bag and rotated into position using the noncompany hook.

• 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: 24019493
• Report Number: 1119421-2026-00076
• Device Sequence Number: 10590935
• Product Code: HQL
• UDI-Device Identifier: 00380652251549
• UDI-Public: (01)00380652251549(17)290601(11)250603(10)16050720
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/09/2026

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.230
• Device Lot Number: 16050720
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 01/09/2026
• Date Device Manufactured: 06/03/2025
• 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: ANGLED FORCEPS; CYCLODIALYSIS SPATULA; SINSKEY HOOK; UNSPECIFIED VISCOELASTIC
• Patient Sex: Unknown