MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF ASPHERIC UV ABSORBING SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number	SA60WF
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A nurse reported that an intraocular lens (iol) had rift after insertion.The lens was inspected before loading, and the same nurse loaded it as per usual practice, using the same viscoelastic and the same type of cartridge.Additional information has been requested, received and stated the lens was carefully inspected before loading and no tears was observed.After the lens unfolded in the patient eye a significant tear was seen.The tear must have occurred in connection with the loading of the lens.During loading, the utmost care was taken, the optic was not touched, and all contact was made only with the haptics.The company cartridge was used.
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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• Brand Name: ACRYSOF ASPHERIC UV ABSORBING 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: 25112986
• Report Number: 1119421-2026-00988
• Device Sequence Number: 21162664
• Product Code: HQL
• UDI-Device Identifier: 00380652332705
• UDI-Public: (01)00380652332705(17)300825(11)250827(10)16101299
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/07/2026

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: SA60WF
• Device Catalogue Number: SA60WF.220
• Device Lot Number: 16101299
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 05/07/2026
• Date Device Manufactured: 08/27/2025
• 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: MONARCH IOL DELIVERY SYSTEM, CARTRIDGE.; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE.
• Patient Age: 77 YR
• Patient Sex: Female