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

Model Number	AU00T0
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A pharmacist reported that during surgery the surgeon noticed that the lens was peripherally cracked and the implant left in the patient eye.Additional information has been requested.
Additional Manufacturer Narrative
The product was not returned.A photo was provided.The surgery suite is shown with equipment.The lens was displayed on a monitor screen.The lens was inside the eye.One side of the optic appears to be cracked and possibly torn.No further determinations can be made from the photo.Product history records were reviewed and the documentation indicated the product met release criteria.Viscoelastic information was not provided.It is unknown if a qualified viscoelastic was used.Based on our observation of the attached photo, the was cracked and possibly torn.It is difficult to make a final determination without evaluation of the physical sample.The root cause cannot be determined based on available information.Information was provided of an unspecified viscoelastic.It is unknown if a qualified viscoelastic was used.The instructions for use (ifu) instructs: during device preparation and implantation of the company preloaded delivery system, an company qualified ophthalmic viscoelastic device (ovd) should be used.The use of an unqualified ovd may cause damage to the lens and potential complications during the device preparation and implantation steps.File will be reopened if new information is received.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been received and it states that the patient underwent cataract surgery on the right eye.After placement of an implant in the already fissured bag at the exit of the injector approximately 1 mm at the extreme periphery of optics and decided to leave it in place because the crack was outside the optical axis.

• Brand Name: ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM
• Common Device Name: INTRAOCULAR LENS
• 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: 22075819
• Report Number: 1119421-2025-01467
• Device Sequence Number: 21180700
• Product Code: HQL
• UDI-Device Identifier: 00380652394703
• UDI-Public: (01)00380652394703(17)270115(11)240117(10)15785729
• Combination Product (Y/N): N
• Initial Reporter Country: NC
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2025

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: AU00T0
• Device Lot Number: 15785729
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2025
• Supplement Date Received by Manufacturer: 06/02/2025
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 06/27/2025
• Date Device Manufactured: 01/17/2024
• 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: 15 DEGREE KNIFE.; 2.2 MM KNIFE.; BANDAGE.; BETADINE OPHTHALMIC 5%.; BETADINE SCRUB 4%.; CEFUROXIME 0.1 ML.; CYSTITOME.; STERDEX OINTMENT.; UNSPECIFIED VISCOELASTIC.
• Patient Sex: Unknown