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	Hyphema (1911)
Date of Event	12/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A healthcare professional reported that during intraocular lens implantation the surgeon seen that the iris was continuous bleeding.The lens was removed during initial procedure.The procedure was completed.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 pmma single piece anterior chamber intraocular lens (iol) is an optical implant designed to be positioned anterior to the iris.The lens should replace the optical function (but not the accommodation) of the natural crystalline lens.The physical properties of these lenses as well as the sizing guidance for these anterior chamber lenses is provided in the instructions for use (ifu).Sizing guidance company model is designated for use with anterior chamber diameter 11.5-11.9.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The lens was returned for evaluation.Solution is dried on the lens.The haptics are fractured in the gusset area.Scratches are observed along the edge of the optic.Product history records were reviewed and the documentation indicated the product met release criteria.Lens damage was observed.The product investigation could not identify a root cause for the reported complaint.It is unclear if the reporter is saying the bleeding was caused from the device or patient anatomical condition.Due diligence has been performed in an attempt to obtain further information on this event.The reporter has not responded to request for follow up information.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; 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: 21091662
• Report Number: 1119421-2025-00088
• Device Sequence Number: 8721658
• Product Code: HQL
• UDI-Device Identifier: 00380650701237
• UDI-Public: (01)00380650701237(17)270308(11)220310(10)15353977
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: P880087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2025

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: MTA3U0.175
• Device Lot Number: 15353977
• 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: 12/15/2024
• Supplement Date Received by Manufacturer: 02/28/2025
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 03/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown