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	10/27/2025
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 during implantation.There was no patient contact.The surgery was completed on the same day using another company lens.Additional information was requested.
Additional Manufacturer Narrative
The product was returned for analysis, and the reported complaint was observed.Iol returned positioned incorrectly in the iol case.Solution is dried on the iol (intraocular lens).The optic is torn/split-cut dividing the iol in three; two optic pieces are adhered to each other with solution.One haptic is broken/torn and not returned, there are marks on other haptic.The complainant indicates the use of one of company delivery device, which is not qualified for use with associated iol model.While we are unable to determine the origin of the reported complaint, our observations reasonably suggest that it is not manufacturing related.Based on the information provided by the customer, the most likely root cause is failure to follow ifu (instructions for use), as the surgeon states the use of non-qualified combination.The use of an unqualified combination may cause damage to the iol and potential complications during the implantation process.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: 23809863
• Report Number: 9612169-2025-02521
• Device Sequence Number: 18489138
• Product Code: HQL
• UDI-Device Identifier: 00380652555807
• UDI-Public: (01)00380652555807(17)290425(11)240427(10)25836642
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2026

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 Model Number: SA60AT
• Device Catalogue Number: SA60AT.200
• Device Lot Number: 25836642
• 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: 11/20/2025
• Supplement Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CLAREON MONARCH IV, INJECTOR; MONARCH III CARTRIDGE C
• Patient Sex: Unknown