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

Model Number	SA60AT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2025
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 physician reported that during an intraocular lens (iol) implant procedure, haptic was broken in the bag while implanting.There was no intervention and no patient harm.
Additional Manufacturer Narrative
Additional information was provided in d.9., h.3., h.6 and h.11.The product was returned for analysis and the reported complaint was observed.Approximately half of the intra ocular lens (iol) received positioned incorrectly in the iol case.Half of the optic and one haptic returned.Substantial amount of solution and blood-like substance are dried on the iol.One haptic is bent or deformed, the tip of the haptic is broken and not returned.The other haptic is not returned.A product history record review and a non-conformance review of the reported lot number was conducted.No deviations, were identified and all corresponding production release specifications defined in the device master record were met.We are unable to determine the root cause for the reported complaint haptic was broken in the bag while implanting.The iol was subject to handling.Only half the iol was returned with substantial amount of solution dried on it.The reported complaint is lacking in relevant information such as associated products used to complete a thorough investigation.Due to the lack of information, we are unable to verify if the iol contributed to the event.In addition to this, all iols are 100 percent cosmetically inspected as per approved manufacturing procedures and the observed lens damage or 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).

• 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: 21864478
• Report Number: 9612169-2025-00638
• Device Sequence Number: 4695528
• Product Code: HQL
• UDI-Device Identifier: 00380652555876
• UDI-Public: (01)00380652555876(17)290423(11)240425(10)25836682
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2025

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.235
• Device Lot Number: 25836682
• 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: 03/21/2025
• Supplement Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 04/18/2025
• Supplement Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2024
• 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