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

Model Number	MA60AC
Medical Device Problem Code	Inaccurate Delivery (2339)
Health Effect - Clinical Codes	Capsular Bag Tear (2639); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A healthcare professional reported that during a cataract surgery with intraocular lens (iol) implant procedure, there was complication happened upon lens delivery after the iol was implanted into the eye.Lens was explanted and replaced with another lens during the initial procedure.There was no patient harm.
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 manufacturer internal reference number is: (b)(4).
Event or Problem Description
A healthcare professional reported that during a cataract surgery with intraocular lens (iol) implant procedure, there was complication happened upon lens delivery after the iol was implanted into the eye.Lens was explanted and replaced with another lens during the initial procedure.There was no patient harm.Additional information was received by stating, upon lens delivery, a complication had occurred in the form of a posterior capsule rupture.

• 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: 22726157
• Report Number: 1119421-2025-02158
• Device Sequence Number: 15525888
• Product Code: HQL
• UDI-Device Identifier: 00380652552561
• UDI-Public: (01)00380652552561(17)260927(11)210929(10)15279653
• 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): 10/22/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/27/2026
• Device Model Number: MA60AC
• Device Catalogue Number: MA60AC.220
• Device Lot Number: 15279653
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/13/2025
• Supplement Date Received by Manufacturer: 09/29/2025
• Initial Report FDA Received Date: 08/06/2025
• Supplement Report FDA Received Date: 10/22/2025
• Date Device Manufactured: 09/29/2021
• 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; MONARCH II IOL DELIVERY SYSTEM, CARTRIDGE B; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; UNSPECIFIED REPLACEMENT LENS; UNSPECIFIED REPLACEMENT LENS
• Outcome Attributed to Adverse Event: Other
• Patient Age: 68 YR
• Patient Sex: Male