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	Visual Disturbances (2140)
Date of Event	07/01/2025
Type of Reportable Event	Malfunction
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).
Event or Problem Description
A non healthcare professional reported that, 10 years after intraocular lens implantation surgery, the patient was increasingly seeing a veil of gray in one eye.The ophthalmologist said that it was not a secondary cataract, but the lens itself that had become cloudy.Additional information was received stating that, the ophthalmologist informed the patient that the issue in the left eye (os) was not a posterior capsule opacification but rather an opacification of the lens.A replacement of the lens is currently not planned as the patient was still having good visual acuity.
Event or Problem Description
Additional information was received stating that the patient underwent a comprehensive outpatient examination.The examinations revealed that the issue was a capsular block syndrome in the left eye.An immediate yag laser capsulotomy was performed without complications, and clear vision was restored within minutes.The patient was provided with anti-inflammatory drug three times daily and a carbonic anhydrase inhibitor once.
Additional Manufacturer Narrative
Additional information was provided in b.5.And h.11.Additional information has been received and indicated that ¿the patient underwent a comprehensive outpatient examination.The examinations revealed that the issue was a capsular block syndrome (posterior capsular opacification (pco)) in the left eye.An immediate yag laser capsulotomy was performed without complications, and clear vision was restored within minutes.¿.Pco is a common complication after cataract surgery and is expected.Yag capsulotomy is the treatment of pco.Based on this information this event no longer meets reporting criteria per applicable regulation, because it did not directly or indirectly lead, nor was it likely to lead to death or serious deterioration of health, or a serious public health threat.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: 22885035
• Report Number: 9612169-2025-01700
• Device Sequence Number: 9057408
• Product Code: HQL
• UDI-Device Identifier: 00380652555845
• UDI-Public: (01)00380652555845(17)200831(11)150917(10)21141851
• 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,Health Professional
• 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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: SA60AT
• Device Catalogue Number: SA60AT.220
• Device Lot Number: 21141851
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/31/2025
• Supplement Date Received by Manufacturer: 12/06/2025
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 12/31/2025
• Date Device Manufactured: 09/17/2015
• 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
• Patient Age: 80 YR
• Patient Sex: Male