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	Insufficient Information (4580)
Date of Event	08/07/2024
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 healthcare professional reported with the description of haze on intraocular lens (iol).Additional information received stating that as per surgeons opinion iol contributed to event.
Additional Manufacturer Narrative
Corrected information was provided in d.4.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The product was not returned for analysis.Only photo was returned.Regarding the report of haze on a single-piece intraocular lens (iol), these moderately blurry images/photographs show a diffuse, non-uniform white haze extending across the visible areas in the parallelepiped slit image, affecting the anterior and posterior subsurface of the iol.While the identity of the haze cannot be confirmed from this photo review alone, its appearance may suggest subsurface nanoglistenings (ssng), characterized by a whitening effect caused when light entering the eye reflects and scatters off nanosized fluid-filled vacuoles within the lens subsurface.This scattering creates a diffuse whitening or haze effect in the iol subsurface.Further evaluation is needed to accurately identify the haze and determine its relevance to the complaint investigation.The root cause for the reported complaint could not be determined.Based on our observation on the returned photos, they show a diffuse, non-uniform white haze extending across the visible areas in the parallelepiped slit image, affecting the anterior and posterior subsurface of the iol.Impact on the vision cannot be determined from the photos.A definitive determination of haze cannot be made from the returned photos - the provided photos are consistent with haze.Based on the results from the product history record, the products met release criteria.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: 20201322
• Report Number: 9612169-2024-00884
• Device Sequence Number: 6815195
• Product Code: HQL
• UDI-Device Identifier: 00380652555968
• UDI-Public: (01)00380652555968(17)170228(11)120313(10)21053768(21)21053768139
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/05/2024

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: 02/28/2017
• Device Model Number: SA60AT
• Device Catalogue Number: SA60AT.280
• Device Lot Number: 21053768
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/14/2024
• Supplement Date Received by Manufacturer: 09/13/2024; 11/07/2024
• Initial Report FDA Received Date: 09/12/2024
• Supplement Report FDA Received Date: 10/08/2024; 12/05/2024
• Date Device Manufactured: 03/13/2012
• 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: 12 MO
• Patient Sex: Female