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	03/04/2026
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.Photo review: 1st photo shows a closed iol case inside an iol pouch.Second and third photos show an iol in a lens case base.One haptic appears to be broken and not present.Fourth photo shows an iol carton with a closed iol pouch on top with a closed lens case inside.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 customer reported that during an intraocular lens (iol) implant procedure, during the assembly of the iol in a cartridge, one haptic coil of the iol was amputated during progression in the injector advancement.The surgery was completed on the same day with another lens.There were no patient contact and harm.

• 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: 24761700
• Report Number: 9612169-2026-00723
• Device Sequence Number: 9248672
• Product Code: HQL
• UDI-Device Identifier: 00380655093214
• UDI-Public: (01)00380655093214(17)300522(11)250524(10)26038382
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/01/2026

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.210
• Device Lot Number: 26038382
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 04/02/2026
• Date Device Manufactured: 05/24/2025
• 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 IOL DELIVERY SYSTEM, CARTRIDGE; MONARCH IOL DELIVERY SYSTEM, INJECTOR, UNSPECIFIED; VISCOELASTIC-SODIUM HYALURONATE (LOT: 130496BFA)
• Patient Age: 76 YR
• Patient Sex: Male