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

Model Number	MTA3U0
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A non-healthcare professional reported during intraocular lens (iol) implant procedure, the lens not stable after insertion in the eye.The lens was explanted and replaced with another unspecified lens during initial procedure.The procedure was completed on same day without any harm to the patient.Additional information has been requested.
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
Additional information has been received stating company lens was replaced with non company polyvinylidene fluoride (pvdf) lens.
Additional Manufacturer Narrative
The lens was returned in the lens case inside the lens carton.Viscoelastic was dried on the lens.No damage was observed.The lens was cleaned for further evaluation.A dimensional inspection was conducted.The lens dimensions (plan view) met specifications per an approved template.Product history records were reviewed and documentation indicated the product met release criteria.A viscoelastic was indicated.The product investigation could not identify a root cause for the reported complaint of "lens not stable after insertion in the eye".It is not possible to confirm the reported unstable position of the lens in the eye based on the product evaluation.The explanted lens was returned and evaluated.There was no damage observed to the lens.After removal of the dried viscoelastic, a dimensional inspection was conducted.The lens dimensions (plan view) met specifications per an approved template.Information was provided that the company diopter lens was removed and replaced with a non-company lens.The diopter of the replacement lens was not provided.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: 19467536
• Report Number: 1119421-2024-01077
• Device Sequence Number: 3418769
• Product Code: HQL
• UDI-Device Identifier: 00380650701220
• UDI-Public: (01)00380650701220(17)260317(11)210319(10)15156496(21)15156496037
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2024

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: 03/17/2026
• Device Model Number: MTA3U0
• Device Catalogue Number: MTA3U0.170
• Device Lot Number: 15156496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/09/2024
• Supplement Date Received by Manufacturer: 08/01/2024
• Initial Report FDA Received Date: 06/05/2024
• Supplement Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2021
• 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; UNSPECIFIED REPLACEMENT LENS
• Patient Age: 81 YR
• Patient Sex: Female