MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. ACRYSOF SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number	SA60AT
Medical Device Problem Code	Material Opacification (1426)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	12/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported after an intraocular lens (iol) implant procedure on (b)(6) 2017, during long term follow up on (b)(6) 2025, diffuse opacification of the intraocular lens was identified, observed under slit-lamp examination, compromising the visual axis and reducing visual acuity.The opacification appeared diffuse and complete, consistent with a material alteration, not related to posterior capsular opacification, inflammatory deposits, or other secondary causes.As clinical consequences, there was a reduction in visual acuity for the patient.After a complete clinical evaluation, no other ocular changes were identified that could explain the condition presented.The recommendation was explant of the intraocular lens and replacement with a new one as a therapeutic measure.To date, the patient remained under regular ophthalmologic follow-up, properly informed about the progression of the condition and the available therapeutic options.Additional information was requested.
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 SINGLEPIECE IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 23976619
• Report Number: 9612169-2026-00034
• Device Sequence Number: 4786585
• Product Code: HQL
• UDI-Device Identifier: 00380652555838
• UDI-Public: (01)00380652555838(17)210331(11)160413(10)21157791
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/06/2026

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 Expiration Date: 03/31/2021
• Device Model Number: SA60AT
• Device Catalogue Number: SA60AT.215
• Device Lot Number: 21157791
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 01/06/2026
• Date Device Manufactured: 04/13/2016
• 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
• Patient Sex: Unknown