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	02/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A facility representative reported that during an intraocular lens (iol) implant procedure, it was noticed lens was unstable and tilted after implanted.Subsequently, it was removed during initial procedure.Additional information was requested.
Additional Manufacturer Narrative
The lens was returned for evaluation.Solution is dried on the lens.Blood is observed in the lens case.The lens was cleaned for further evaluation.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.No damage is observed to the lens.The product investigation could not identify a root cause for the reported complaint.A dimensional inspection was performed.The lens dimensions are acceptable (plan view) using an approved template.The 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 ifu.Sizing guidance is provided in the ifu.The is designated for use with anterior chamber diameter 11.5-11.9.No further information has been provided at this time.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: 19520268
• Report Number: 1119421-2024-01136
• Device Sequence Number: 15556565
• Product Code: HQL
• UDI-Device Identifier: 00380650701244
• UDI-Public: (01)00380650701244(17)260809(11)210811(10)15217317(21)15217317093
• 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): 09/16/2024

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: 08/09/2026
• Device Model Number: MTA3U0
• Device Catalogue Number: MTA3U0.180
• Device Lot Number: 15217317
• 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: 05/15/2024
• Supplement Date Received by Manufacturer: 08/23/2024
• Initial Report FDA Received Date: 06/12/2024
• Supplement Report FDA Received Date: 09/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2021
• 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: 62 YR
• Patient Sex: Male