MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number	SN60AT
Medical Device Problem Code	Material Opacification (1426)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/26/2025
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 physician reported with a description of the intraocular lens had superficial coating or film.The lens remains implanted.It was barely visible during the visual inspection before.Additional information was requested, but no further information is available.
Additional Manufacturer Narrative
Additional information: the lens remains implanted.The provided photo was reviewed.The photo was an anterior segment photo of an iol through a mid dilated pupil.The photo was focused on the anterior iol surface.There appeared to be a minimally dense opaque appearance with a few isolated dense spots within the lighter dense area.It is not possible to determine what exactly is on the lens surface.The most common cause of anterior intraocular lens (iol) opacities in the first week after cataract surgery is the deposition of inflammatory debris or fibrin on the lens surface.Company lenses do not have a coating.Company lenses do not have a coating.The provided photo was reviewed.The photo was an anterior segment photo of an iol through a mid dilated pupil.The photo was focused on the anterior iol surface.There appeared to be a minimally dense opaque appearance with a few isolated dense spots within the lighter dense area.It is not possible to determine what exactly is on the lens surface.The most common cause of anterior intraocular lens (iol) opacities in the first week after cataract surgery is the deposition of inflammatory debris or fibrin on the lens surface.Due diligence has been performed in an attempt to obtain further information on this event.The reporter is unwilling to provide further information.File will be reopened if new information is received.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information was provided in b.5.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been received and stated that the coating was there immediately, sometimes already in the packaging and it stays for the long term.

• Brand Name: ACRYSOF SINGLEPIECE IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 21918025
• Report Number: 1119421-2025-01198
• Device Sequence Number: 21031711
• Product Code: HQL
• UDI-Device Identifier: 00380650130280
• UDI-Public: (01)00380650130280(17)291022(11)241024(10)15939107
• 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: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/17/2025

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 Model Number: SN60AT
• Device Catalogue Number: SN60AT.190
• Device Lot Number: 15939107
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/01/2025
• Supplement Date Received by Manufacturer: 05/08/2025; 06/25/2025
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 05/30/2025; 07/17/2025
• Date Device Manufactured: 10/24/2024
• 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