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

Model Number	SA60WF
Medical Device Problem Codes	Failure to Unfold or Unwrap (1669); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2026
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.Three photos were provided.The photos appear to be identical.The photos were an image of a monitor screen showing a portion of the eye in the background.A clear lens model was shown held by one haptic with a metal instrument for the photo.Solution was observed on the lens and on the lens case, outside the well area.The lens was posterior surface up.One haptic distal tip was broken.The broken haptic tip was not visible in the image.A large portion of the optic edge was broken starting from the haptic/optic junction of the broken haptic and travelling around a portion of the optic edge.A separate area of the optic edge was torn, crushed, and cracked.A third area of the optic edge appeared to also be damaged.No further confirmations can be made from the photo.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, when surgeon intended to implant the lens, while grasping the lens and preparing to insert it into the cartridge, surgeon noticed that something was wrong with the lens.Upon closer inspection, it was observed that one of the lens haptics was caught within the optical portion of the lens, causing the lens to tear.The backup lens was used.There was no patient harm.

• 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: 24222369
• Report Number: 1119421-2026-00201
• Device Sequence Number: 8326154
• Product Code: HQL
• UDI-Device Identifier: 00380652332781
• UDI-Public: (01)00380652332781(17)291215(11)241217(10)15969108
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• 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: Other
• Device Model Number: SA60WF
• Device Catalogue Number: SA60WF.260
• Device Lot Number: 15969108
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 01/30/2026
• Date Device Manufactured: 12/17/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Patient Sex: Unknown