MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ TORIC SINGLEPIECE IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	SN6AT4
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported that during cataract surgery with intraocular lens (iol) implantation, the cartridge broke at the implantation stage and consequently led to damage of the implanted lens.The lens was later removed in a secondary procedure.There was no further impact to the patient.Additional information has been requested but is not available at the time of this report.
Additional Manufacturer Narrative
The 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).
Additional Manufacturer Narrative
Additional information provided in section d.10.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.
Additional Manufacturer Narrative
Additional information provided in sections d.9., h.3., h.6., and h.11.The lens was returned adhered to the outside of a company provided iii (c) cartridge inside a small plastic pouch.The lens had a small amount of viscoelastic dried on it.The optic had a large scrape mark on the posterior surface, which started at the trailing haptic gusset and travelled inward.This damage was similar to damage caused by a plunger underride.A device history record review and a non-conformance review of the reported lot number was conducted.The deviation review did not reveal any potential contributing factors to the reported complaint and all corresponding production release specifications defined in the device master record were met.A non-qualified company provided iii (d) cartridge was indicated and a non-qualified company provided iii (c) cartridge was returned with the sample.The company provided, 33.0 diopter intraocular lens (iol) is only qualified for use with the company provided ii (b) cartridge.The correct cartridge is indicated on the lens case and lens carton labels.The lens optic had a large scrape mark on the posterior surface, which started at the trailing haptic gusset and travelled inward.This damage was similar to damage caused by a plunger underride.The root cause for the damage would be related to a failure to follow the instructions for use (ifu).The company provided, 33.0 diopter iol is only qualified for use with the company provided ii (b) cartridge.The correct cartridge is indicated on the lens case and lens carton labels.The ifu instructs: company provided foldable iols are qualified for use with a company provided qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The ifu instructs that a company provided qualified delivery system and viscoelastic combination should be used.The use of an unqualified combination may cause damage to the lens and potential complications during the implantation process.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.

• Brand Name: ACRYSOF IQ TORIC SINGLEPIECE IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 24858667
• Report Number: 1119421-2026-00762
• Device Sequence Number: 10549778
• Product Code: MJP
• UDI-Device Identifier: 00380652250658
• UDI-Public: (01)00380652250658(17)290728(11)240730(10)15900201
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SN6AT4
• Device Catalogue Number: SN6AT4.330
• Device Lot Number: 15900201
• 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: 03/20/2026
• Supplement Date Received by Manufacturer: 04/16/2026; 06/30/2026
• Initial Report FDA Received Date: 04/13/2026
• Supplement Report FDA Received Date: 05/11/2026; 07/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2024
• 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: CENTURION VISION SYSTEM, ACCESSORY, OZIL HANDPIECE; CENTURION VISION SYSTEM, ACCESSORY, OZIL HANDPIECE.; CROWNVISC 1.6% 1.0 ML, LOT 2611202578; CROWNVISC 1.6% 1.0 ML, LOT 2611202578.; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.; UNSPECIFIED CARTRIDGE; UNSPECIFIED CARTRIDGE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Unknown