MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF MULTIPIECE IOL; INTRAOCULAR LENS

Model Number	MA60AC
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Zonular Dehiscence (2698)
Date of Event	10/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A health care professional reported that during an intraocular lens (iol) implant procedure, the lens was unstable in the capsule after implantation and suspected zonulariysis.Replacement lens used.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).
Additional Manufacturer Narrative
The lens was returned positioned incorrectly in the lens case.Blood and solution was dried on the lens.The lens was cleaned with klrp (klotho-related protein) for further evaluation.A dimensional inspection was conducted.The lens met specifications per the approved (plan view) template.No haptic or optic damage observed.Qualified associated products were indicated.The lens was cleaned with klrp for further evaluation.A dimensional inspection was conducted.The lens met specifications per the approved (plan view) template.No haptic or optic damage observed.Information was provided that the lens was unstable in the capsule due to suspected zonular dialysis.Due diligence has been performed in an attempt to obtain further information on this event.File will be reopened and updated if new information is received.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF MULTIPIECE 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: 21571420
• Report Number: 1119421-2025-00644
• Device Sequence Number: 8737970
• Product Code: HQL
• UDI-Device Identifier: 00380652552509
• UDI-Public: (01)00380652552509(17)270404(11)220406(10)15377883
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: P930014
• 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): 05/30/2025

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: MA60AC
• Device Catalogue Number: MA60AC.190
• Device Lot Number: 15377883
• 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: 02/11/2025
• Supplement Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2022
• 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: DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE.; MONARCH II IOL DELIVERY SYSTEM, CARTRIDGE B.; MONARCH III IOL DELIVERY SYSTEM, INJECTOR.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 75 YR
• Patient Sex: Male