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

Model Number	SA60AT
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	02/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A non-healthcare professional reported that after the patient had an intraocular lens (iol) implanted in 2021 and the patient underwent semi-annual examination, it was discovered that a glistening had formed.The patient would like information on whether this is normal or if anything can be done about it.Additional information has received it stated that the patient reported that she was first diagnosed with glistening in (b)(6) 2025 during her six-monthly ophthalmologist appointment.In (b)(6) 2021, she had the iol implanted, after she had an iol with an incorrect diopter implanted in (b)(6) 2021 and a tear in the iol was also detected during the operation.Since her right eye has already been operated on twice and a secondary cataract was also lasered and there were also some complications during the 2nd operation, the change is currently the last possible option for her.She would just be interested to know if there are any tips on how she can act to prevent further progression or if there is any research into whether the formation of microvacuoles can be stopped.So far, she has mainly been affected by driving in the dark.Additional information has received it stated that the patient was implanted with non-company lens in october.It had a tear and was then explanted in december and replaced with an company iol.
Additional Manufacturer Narrative
This report originally filed as (b)(4).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: 22083562
• Report Number: 9612169-2025-01107
• Device Sequence Number: 8022230
• Product Code: HQL
• UDI-Device Identifier: 00380650141286
• UDI-Public: (01)00380650141286(17)250831(11)201005(10)21283414
• 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: 2021
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/26/2025

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: 08/31/2025
• Device Model Number: SA60AT
• Device Catalogue Number: SA60AT.320
• Device Lot Number: 21283414
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 05/26/2025
• Date Device Manufactured: 10/05/2020
• 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: Other
• Patient Age: 56 YR
• Patient Sex: Female