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	Capsular Bag Tear (2639)
Date of Event	01/04/2022
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 healthcare professional reported that, during cataract surgery with intraocular lens implantation, the posterior capsule ruptured upon delivery of lens into the eye.Hence the lens was removed and replaced with another lens during the same procedure.There was no patient harm.
Additional Manufacturer Narrative
Additional information was provided in d.9., d.10., h.3., h.6.And h.11.The lens was returned inside the replacement lens case.Solution was dried on the lens.One haptic was broken (possibly cut) from the haptic/optic junction area (not returned).The optic as cut in half, typical of insertion and removal.The device was returned loose inside the carton.The plunger lock and lens stop have been removed from the device.The plunger was oriented correctly.Viscoelastic was observed in the device.The plunger was retracted back to mid-nozzle.No abnormalities observed.Product history records were reviewed and the documentation indicated the product met release criteria.The product investigation could not identify a root cause for the reported complaint.Information was provided that the capsule was ruptured upon inserting the lens.The lens was exchanged for a 22.5 diopter lens model.No further information has been provided.File will be re-opened and updated if new information is received.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
There was no further impact to the patient.
Additional Manufacturer Narrative
Additional information was provided in b.3., b.5., h.3., h.6.And h.11.No abnormalities were observed with the returned delivery system.Improper delivery was not indicated.It cannot be determined what caused the rupture based on the available information.No further information has been provided.File will be reopened and updated if new information is received.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: 21641745
• Report Number: 1119421-2025-00750
• Device Sequence Number: 12668753
• Product Code: KYB
• UDI-Device Identifier: 00380652394840
• UDI-Public: (01)00380652394840(17)230622(11)200622(10)15079170
• 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): 07/30/2025

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 Expiration Date: 06/22/2023
• Device Model Number: AU00T0
• Device Lot Number: 15079170
• 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: 02/20/2025
• Supplement Date Received by Manufacturer: 05/06/2025; 07/07/2025
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 05/29/2025; 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2020
• 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 OPHTHALMIC VISCOSURGICAL DEVICE.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 56 YR
• Patient Sex: Male