MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON 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	03/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A healthcare professional reported with the description of intraocular lens (iol) got opaque which was implanted in the year 2007.Additional information has been received and stated that the iol was explanted in a secondary procedure.
Additional Manufacturer Narrative
Additional information was provided in d.9., h.3., h.6.And h.11.The lens was returned from ftw, dry in a centrifuge tube.No opacification was observed.The lens had multiple areas of yag pitting across the central portion of the optic.Power and resolution were verified.The lens met specifications for a company model, 23.0 diopter lens.Testing conducted at ftw indicated the lens was not opacified.The observed phenomenon was most likely hydration dependent light scattering which is not visible in a dry date.Product history records were reviewed, and documentation indicated the product met release criteria.The root cause for the reported issue could not be verified.The returned lens was not opacified.It was stated that the lens implanted in 2007 when the patient was 13 years old looked opacified.It is unclear if the patient was having visual issues.The returned lens power and resolution were verified, and the lens met specification.The lens was clear in a dry state.Testing conducted at ftw indicated the lens was not opacified.The observed phenomenon was most likely hydration dependent light scattering which is not visible in a dry date.Information was provided that due to fibrosis and weak zonules the patient was implanted noncompany 20.5 diopter poly methyl methacrylate iol which is a difference of 2.5 diopters.Information on the lens findings were provide to the surgeon.No further requests were made.File will be reopened if new information is received.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
On initial mdr the imdrf health event code of f24 was an error.It should have been f1903 on the original mdr.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF SINGLEPIECE IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 19040243
• Report Number: 1119421-2024-00615
• Device Sequence Number: 15594733
• Product Code: HQL
• UDI-Device Identifier: 00380652555869
• UDI-Public: (01)00380652555869(17)110930(11)061009(10)136294(21)136294.036
• 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: 2007
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/05/2025

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: 09/30/2011
• Device Model Number: SA60AT
• Device Catalogue Number: SA60AT.230
• Device Lot Number: 136294
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/08/2024
• Supplement Date Received by Manufacturer: 07/01/2024; 02/06/2025
• Initial Report FDA Received Date: 04/04/2024
• Supplement Report FDA Received Date: 07/29/2024; 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2006
• 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 Sex: Unknown