MAUDE Adverse Event Report: Alcon Research, LLC - Huntington AcrySof Aspheric UV Absorbing Singlepiece IOL; Intraocular Lens

Model Number	SA60WF
Medical Device Problem Code	Material Opacification (1426)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported that, following an intraocular lens (iol) implantation procedure, the lens became opacified.Furthermore reported that there had been no manipulation of the eye since the surgery performed 6 years ago.Additional information has been requested and received stating that they observed an iol opacification without inciting event and any additional surgeries or procedures in eye since the surgery.There was no further impact 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 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 ; +1(800)757-9780
• MDR Report Key: 50101375
• Report Number: 1119421-2026-01604
• Device Sequence Number: 12075687
• Product Code: HQL
• UDI-Device Identifier: 00380652332699
• UDI-Public: (01)00380652332699(17)230331(11)180412(10)12610601
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: SA60WF
• Device Catalogue Number: SA60WF.215
• Device Lot Number: 12610601
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/10/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/09/2026
• Supplement Date Received by Manufacturer: 08/03/2026
• Initial Report FDA Received Date: 07/31/2026
• Supplement Report FDA Received Date: 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2018
• 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 McPhersons forceps.; MONARCH III Cartridge C.; Unspecified handpiece.; Unspecified viscoelastic.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male