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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional reported with the description of intraocular lens was unstable after implantation.The lens was removed during the initial procedure and replaced with the other lens.No patient harm was reported.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).
Event or Problem Description
Additional information has been received and stated that the size of the lens does not fit with the size of the eye resulting in instable iol in the eye.
Additional Manufacturer Narrative
The lens was returned for evaluation.Solution is dried on the lens.The lens is fractured in one of the gusset areas.A dimensional inspection was performed.The lens dimensions are acceptable (plan view) using an approved template.Product history records were reviewed and the documentation indicated the product met release criteria.The root cause for the lens instability could not be determined by the product investigation.The lens dimensions were acceptable (plan view) using an approved template.Information was provided that the lens and the patients eye size we not compatible.Sizing guidance is provided in the ifu.The company model is designated for use with anterior chamber diameter 11.5-11.9.File will be reopened if new information is received.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; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 21420617
• Report Number: 1119421-2025-00452
• Device Sequence Number: 7854994
• Product Code: HQL
• UDI-Device Identifier: 00380650701251
• UDI-Public: (01)00380650701251(17)260224(11)210226(10)15148322
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2025

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 Expiration Date: 02/24/2026
• Device Model Number: MTA3U0
• Device Catalogue Number: MTA3U0.185
• Device Lot Number: 15148322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2025
• Supplement Date Received by Manufacturer: 03/11/2025
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 04/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2021
• 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 Age: 56 YR
• Patient Sex: Male