MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ NATURAL SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number	SN60WF
Medical Device Problem Codes	Break (1069); Failure to Deliver (2338); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2025
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 nurse reported that during an intraocular lens implant procedure the haptic was deformed or haptic abnormally extended the surgeon was not confident in using on patient.The surgery was completed on the same day.There was no patient contact.Additional information has been received and stated that the trailing haptic was stuck, while retract injector and pulling the lens out the haptic was torn.
Additional Manufacturer Narrative
Corrected information provided in h.6.And h.11.Correction: on initial mdr the product code of a040609 was an error.It should have been a140801 on the original mdr.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ NATURAL SINGLEPIECE 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: 22839202
• Report Number: 1119421-2025-02281
• Device Sequence Number: 18497583
• Product Code: HQL
• UDI-Device Identifier: 00380655093238
• UDI-Public: (01)00380655093238(17)290630(11)240702(10)15883059
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2025

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: SN60WF
• Device Catalogue Number: SN60WF.220
• Device Lot Number: 15883059
• 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: 07/29/2025
• Supplement Date Received by Manufacturer: 09/09/2025
• Initial Report FDA Received Date: 08/19/2025
• Supplement Report FDA Received Date: 09/30/2025
• Date Device Manufactured: 07/02/2024
• 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: MONARCH III IOL , INJECTOR.; MONARCH III IOL, CARTRIDGE C.; VISCOAT OVD.
• Patient Sex: Unknown