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

Model Number	SN60WF
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2025
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 surgeon professional reported that during an intraocular lens (iol) implant procedure, while loading the iol at the time of insertion, the surgeon noticed that the iol haptic was cut.There was no patient harm.The surgery was completed with a replacement of the iol on the same day.Additional information has been requested.
Additional Manufacturer Narrative
The product was returned for analysis and the reported complaint was observed.Intraocular lens (iol) returned positioned correctly in the iol case.Solution is dried on the iol.One haptic is broken/torn and is returned, the other haptic is slightly deformed.The optic edge is damaged/deformed.Received photo shows an iol in a lens case base.One haptic is broken/torn and is loose in the lens case base.We are unable to determine the root cause for the reported complaint "during loading, iol haptic was cutted".The returned iol shows evidence of possible handling by the customer due to the presence of solution dried on the iol.In addition to this, all iols are 100 percent cosmetically inspected as per approved manufacturing procedures and the observed lens damage would not meet our current release criteria.Based on these investigation findings, we are unable to verify that the damage was present when opened and 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 IQ NATURAL 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: 24129243
• Report Number: 9612169-2026-00163
• Device Sequence Number: 12126496
• Product Code: HQL
• UDI-Device Identifier: 00380655093276
• UDI-Public: (01)00380655093276(17)291008(11)241010(10)25927216
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2026

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: SN60WF
• Device Catalogue Number: SN60WF.240
• Device Lot Number: 25927216
• 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: 01/02/2026
• Supplement Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 01/21/2026
• Supplement Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2024
• 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: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Patient Sex: Unknown