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

Model Number	MTA3U0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	10/24/2025
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, patient had posterior capsule rupture due to which surgeon changed lens to provide better outcome to patient.The surgery was completed on the same day and there was no patient harm.Additional information has been requested.
Additional Manufacturer Narrative
Based on information received following submission of the initial report, this event does not meet criteria for reporting as a serious injury.No further reports required.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received and stated that the capsule rupture was due to the patient's anatomy and not related to a device issue.The surgeon decided to implant a different intraocular lens due to patient eye anatomy condition.

• 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: 23552893
• Report Number: 1119421-2025-02934
• Device Sequence Number: 18473367
• Product Code: HQL
• UDI-Device Identifier: 00380650701244
• UDI-Public: (01)00380650701244(17)270309(11)220311(10)15353976
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/25/2025

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 Model Number: MTA3U0
• Device Catalogue Number: MTA3U0.180
• Device Lot Number: 15353976
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/24/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 11/14/2025
• Supplement Report FDA Received Date: 12/25/2025
• Date Device Manufactured: 03/11/2022
• 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: ACRYSOF MULTIPIECE IOL
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown