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

Model Number	SA60AT
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A non-health care professional reported that a lens was damaged.Additional information has been requested.
Additional Manufacturer Narrative
A sample device 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).
Additional Manufacturer Narrative
The product was returned for analysis and the reported complaint could not be confirmed due to the sate of the returned sample.Iol returned adhered to the lens case with an adhesive tape.The lens cannot be removed from the adhesive tape.No obvious damage can be observed to the iol.A further evaluation cannot be conducted due to the condition of the returned sample.No root cause identified as the reported complaint could not be confirmed.The iol could not be removed from the adhesive tape for evaluation.No damage could be seen to the lens in the current state.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: 17117416
• Report Number: 9612169-2023-00447
• Device Sequence Number: 7200433
• Product Code: HQL
• UDI-Device Identifier: 00380652555876
• UDI-Public: 00380652555876
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2023

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.235
• Device Lot Number: 25569533
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/30/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/15/2023
• Supplement Date Received by Manufacturer: 08/03/2023
• Initial Report FDA Received Date: 06/13/2023
• Supplement Report FDA Received Date: 08/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2023
• 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