MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ SINGLEPIECE IOL W/ACRYSERT C DELIVERY SYSTEM; LENS, GUIDE, INTRAOCULAR

Model Number	SN6CWS
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A case received from chinese health authority reported that during an intraocular lens (iol) implantation procedure, surgeon informed that the iol could not be pushed out and immediately replaced it with non-company lens and procedure was completed on the same day without any harm to the patient.
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).

• Brand Name: ACRYSOF IQ SINGLEPIECE IOL W/ACRYSERT C DELIVERY SYSTEM
• Common Device Name: LENS, GUIDE, INTRAOCULAR
• 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: 25360596
• Report Number: 1119421-2026-01180
• Device Sequence Number: 18823769
• Product Code: KYB
• UDI-Device Identifier: 00380652249232
• UDI-Public: (01)00380652249232(17)270409(11)220411(10)15386654
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/02/2026

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: SN6CWS
• Device Catalogue Number: SN6CWS.210
• Device Lot Number: 15386654
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 06/02/2026
• Date Device Manufactured: 04/11/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 87 YR
• Patient Sex: Unknown