MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ANTERIOR CHAMBER PMMA SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number	MTA3U0
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional reported during phacoemulsification surgery with anterior chamber intraocular lens (iol) implantation, the iol casing was opened prior implant into patient's eye.Surgeon used company ophthalmic viscosurgical device (ovd) and glide to implant the iol.When iol in the eye, found the lens not stable and tendency to drop.Surgeon decided not to proceed with implantation and explanted the lens.The patient¿s eye left with aphakia, and surgeon closed the wound and completed the surgery.Additional information has been requested.
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).
Additional Manufacturer Narrative
The lens was returned in the lens case.Viscoelastic and what appeared to be blood were observed on both sides of the lens.One haptic was broken-distal area, not returned.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.The root cause for the reported lens dislocated lens, could not be determined.The returned lens had a broken haptic tip.It cannot be determined if this occurred during the implant or during the removal.All lenses are 100 percentage inspected for cosmetic attributes; damaged or broken haptics would not have met company's release criteria.The manufacturer internal reference number is: (b)(4).

• Brand Name: ANTERIOR CHAMBER PMMA SINGLEPIECE IOL
• 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: 23790737
• Report Number: 1119421-2025-03137
• Device Sequence Number: 10453656
• Product Code: HQL
• UDI-Device Identifier: 00380650701244
• UDI-Public: (01)00380650701244(17)270427(11)220429(10)15391168
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: P880087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2026

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: MTA3U0
• Device Catalogue Number: MTA3U0.180
• Device Lot Number: 15391168
• 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: 11/19/2025
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2022
• 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: DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Patient Sex: Unknown