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	10/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for analysis.The reporter states the use of company cartridge, which is not qualified to be used with the associated iol model.It is not clear from the reported complaint if the lens was loaded into the cartridge or was the damage observed when opened.The files states "the lens in the box has a broken haptic".The root cause for the reported complaint could not be determined.No sample was returned for analysis.The surgeon states the use of non-qualified cartridge.The use of an unqualified combination may cause damage to the iol and potential complications during the implantation process.It is not clear from the reported complaint if the lens was loaded into the cartridge or was the damage observed when opened.The files states "the lens in the box has a broken haptic".No clarification has been received.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A healthcare professional reported that during an intraocular lens (iol) implant procedure, the doctor observed that the lens in the box had a broken haptic.The issue was identified during loading, with no patient contact.Additional information was requested.

• 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: 24161349
• Report Number: 9612169-2026-00179
• Device Sequence Number: 8993779
• Product Code: HQL
• UDI-Device Identifier: 00380652555951
• UDI-Public: (01)00380652555951(17)260529(11)210531(10)25176536
• Combination Product (Y/N): N
• Initial Reporter Country: RO
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/23/2026

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 Expiration Date: 05/29/2026
• Device Model Number: SA60AT
• Device Catalogue Number: SA60AT.275
• Device Lot Number: 25176536
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 01/23/2026
• Date Device Manufactured: 05/31/2021
• 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 DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; UNKNOWN OVD
• Patient Sex: Unknown