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

Model Number	SA60AT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Posterior Capsule Opacification (4807)
Date of Event	08/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A non healthcare professional reported that, four years after intraocular lens implantation surgery, pars plana vitrectomy (ppv) was performed on the right eye due to vitreoretinal traction.During this procedure, a beginning posterior capsule opacification which was subjectively unnoticed was removed.The patient had a clear vision in the right eye.Additional information was received stating that the posterior capsule opacification (pco) was treated on (b)(6) 2019.
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.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).
Additional Manufacturer Narrative
Additional information was provided in b.3., b.5.And b.7.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received stating that the patient was diagnosed with pseudoexfoliation (pex).

• 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: 23001825
• Report Number: 9612169-2025-01789
• Device Sequence Number: 8833409
• Product Code: HQL
• UDI-Device Identifier: 00380652555845
• UDI-Public: (01)00380652555845(17)201031(11)151103(10)21145377
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/31/2025

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: 10/31/2020
• Device Model Number: SA60AT
• Device Catalogue Number: SA60AT.220
• Device Lot Number: 21145377
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/13/2025
• Supplement Date Received by Manufacturer: 12/06/2025
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 12/31/2025
• Date Device Manufactured: 11/03/2015
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male