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

Model Number	SN60AT
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
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 an intraocular lens implant procedure the surgeon noticed the intraocular lens(iol) was defective after implantation.The lens was removed during initial procedure and replaced with the company lens of same diopter.There was no patient harm.Additional information has been requested.
Additional Manufacturer Narrative
The product was returned for analysis and damage was observed to the iol.Lens received in unknown syringe filled with unknown solution.Solution is dried on the iol.One haptic is intact, the other haptic is not present.The optic is torn or split cut dividing the iol in two segments, one segment is missing part of the optic and a haptic.There are a few large scratches on the surface of one of the iol optic segments.The root cause for the reported complaint could not be determined.The reported complaint is lacking in relevant information such as the type of defect or issue observed.Due to the lack of information, we are unable to verify if the product contributed to the event.Damage was observed to the returned iol.All iols are 100percentage cosmetically inspected as per approved manufacturing procedures and the observed lens damage or condition would not meet our current release criteria.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: 22112574
• Report Number: 9612169-2025-01154
• Device Sequence Number: 15243093
• Product Code: HQL
• UDI-Device Identifier: 00380650130365
• UDI-Public: (01)00380650130365(17)280404(11)230407(10)25631547
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 08/05/2025

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.230
• Device Lot Number: 25631547
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/07/2025
• Supplement Date Received by Manufacturer: 07/17/2025
• Initial Report FDA Received Date: 05/30/2025
• Supplement Report FDA Received Date: 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MONARCH III IOL , CARTRIDGE C.; MONARCH III IOL , INJECTOR.; PROVISC OVD.
• Patient Sex: Unknown