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

Model Number	SA60AT
Medical Device Problem Codes	Device Damaged Prior to Use (2284); Defective Device (2588)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A product was not returned for analysis.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 nurse reported that during surgery, they have noticed that the lens was deformed and there was no patient contact.
Additional Manufacturer Narrative
The lens was returned in the lens case inside the opened carton.Solution was dried on the lens.The lens is cut in half, typical of insertion and removal from the eye.Both pieces are adhered to each other by solution.One haptic is folded over and adhered to the optic by solution.Scratches are observed on the optic portion near the area where it is cut along with a longer scratch stretching from the cut area to near the gusset area.All product and batch history records are quality reviewed prior to product release.The product investigation could not identify a root cause for the reported complaint.Lens damage was observed.The observed lens damage is similar in appearance to handling related damage.The presence of the solution on the returned sample is evidence that the product was subjected to handling.Due to the presence of surgical solution, we are unable to verify that the damage was present when opened.File will be reopened if new information is received.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has received and it states that the lens had a patient contact and surgery was completed on the same day.

• 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: 21047493
• Report Number: 1119421-2024-02674
• Device Sequence Number: 3417379
• Product Code: HQL
• UDI-Device Identifier: 00380652555883
• UDI-Public: (01)00380652555883(17)271116(11)221118(10)15534075
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/18/2025

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: SA60AT
• Device Catalogue Number: SA60AT.240
• Device Lot Number: 15534075
• 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: 12/05/2024
• Supplement Date Received by Manufacturer: 01/27/2025; 02/20/2025
• Initial Report FDA Received Date: 12/31/2024
• Supplement Report FDA Received Date: 02/14/2025; 03/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2022
• 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