MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM; LENS, GUIDE, INTRAOCULAR

Model Number	AU00T0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Zonular Dehiscence (2698)
Date of Event	02/25/2025
Type of Reportable Event	Serious Injury
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 health care professional reported that during an intraocular lens (iol) implant procedure, zonulysis after lens implantation.Lens was explanted in initial procedure.The procedure was completed with unspecified multi piece lens.
Additional Manufacturer Narrative
Only the lens was returned.The lens was positioned incorrectly in the base component of the lens case inside the carton.Viscoelastic was dried on the lens.One haptic was bent in the gusset area.The other haptic was broken in the gusset area.The broken haptic was returned in the lens case.Product history records were reviewed and documentation indicated the product met release criteria.Information on the provided product complaint form indicated the use of an associated qualified cartridge, handpiece and viscoelastic.This information indicates that the lens would have been removed from the company preload injector and manually folded into company cartridge.The root cause cannot be determined for the reported complaint of zonulysis after lens implantation, in and out".The lens was returned with evidence of viscoelastic, bent haptic damage and broken haptic damage.It is unknown if the broken haptic damage occurred during a manual removal from the preloaded device and manual folding, loading into the cartridge, delivery into the eye, or if the broken haptic damage was associated with the removal of the lens from the eye.Information was provided that the iol was used with a qualified cartridge, handpiece and viscoelastic.This information indicates that the lens would have been removed from the ultrasert injector and manually folded into company cartridge.The ifu instructs: prior to opening the pre-loaded delivery system, first fill the company cartridge with ovd per the company cartridge ifu.Hold the company preload¿ device main body horizontally with the door facing up.Then, using only a gloved hand that is free of excess ovd and saline solution, grasp the door and lift from the latch side to fully open the door and expose the lens.Visually inspect the lens for damage or adhered particles.Use another device and lens if any damage or adhered particles are detected.Use forceps with rounded, non-serrated blades to grasp the lens by the leading haptic.When removing the lens from the company preload device, do not grasp the optical area with forceps.Information was provided that indicated the company 20.5 diopter lens was removed and replaced with an company 20.0 diopter lens.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information was provided in b.5.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM
• Common Device Name: LENS, GUIDE, INTRAOCULAR
• 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: 21719133
• Report Number: 1119421-2025-00864
• Device Sequence Number: 3808767
• Product Code: KYB
• UDI-Device Identifier: 00380652394772
• UDI-Public: (01)00380652394772(17)270220(11)240222(10)15805760
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/13/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: AU00T0
• Device Lot Number: 15805760
• 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: 02/28/2025
• Supplement Date Received by Manufacturer: 04/14/2025; 01/21/2026
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 05/12/2025; 02/13/2026
• Date Device Manufactured: 02/22/2024
• 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: ACRYSOF MULTIPIECE IOL; DISCOVISC OVD; MONARCH III IOL CARTRIDGE D; MONARCH III IOL INJECTOR
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female