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

Model Number	SA60AT
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Event or Problem Description
A pharmacist reported that during an intraocular lens (iol) implant procedure, the lens was broken in cartridge and no patient impact was reported.Additional information has been requested.There are three medical device reports associated with this report.This is 3 of 3.
Additional Manufacturer Narrative
The product was returned for analysis and damage was observed to the intra ocular lens (iol).No cartridge was returned.Lens received outside of the lens case, wrapped in medical gauze.Solution is dried on the iol.One haptic is broken or torn and is returned adhered to the optic surface.The other haptic has loose fibers adhered to its surface.There are fibers adhered to the optic with solution.We are unable to determine the root cause for the reported complaint lens broken in cartridge.One haptic was observed to be broken.No cartridge was returned, due to this, we are unable to complete a thorough investigation to determine a root cause.In addition to this, all iols are 100 percent cosmetically inspected as per approved manufacturing procedures and the observed lens condition would not meet our current release criteria.Based on these investigation findings, we are unable to verify if the iol contributed to the event.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4), h.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• 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: 22077048
• Report Number: 9612169-2025-01097
• Device Sequence Number: 9374881
• Product Code: HQL
• UDI-Device Identifier: 00380650141309
• UDI-Public: (01)00380650141309(17)280305(11)230308(10)25609308
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2025

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.340
• Device Lot Number: 25609308
• 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: 04/29/2025
• Supplement Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 08/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2023
• 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: UNSPECIFIED CARTRIDGE.
• Patient Sex: Unknown