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

Model Number	MA60AC
Medical Device Problem Codes	Failure to Deliver (2338); Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2024
Type of Reportable Event	Malfunction
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).
Event or Problem Description
A healthcare professional reported during an intraocular lens loading, there was a problem with the haptic, lens was stuck in the cartridge and was not used.Procedure was completed on the same day.There was no patient contact.Additional information has been requested.
Additional Manufacturer Narrative
The lens was returned advanced to the nozzle entry in a qualified company cartridge.Inadequate viscoelastic was observed in the cartridge.Both haptics were in acceptable positions.No haptic issue was observed.The lens was folded correctly.The company cartridge was cleaned for further evaluation.The lens was removed during cleaning.Top coat dye stain testing was conducted with acceptable results.Product history records were reviewed and documentation indicated the product met release criteria.A qualified cartridge was indicated with a non-qualified handpiece.The lens was returned in a cartridge.The lens and haptic positions were acceptable.No haptic issue or damage was observed.The root cause for the reported issue may be related to a failure to follow the instructions for use (ifu).The handpiece indicated is not qualified for use with the company lens model.In addition, inadequate viscoelastic was observed in the cartridge.The ifu instructs: company foldable intraocular lens (iols are qualified for use with an company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The ifu instructs that an company qualified delivery system and viscoelastic combination should be used.The use of an unqualified combination may cause damage to the lens and potential complications during the implantation process.The ifu instructs to completely fill the cartridge with ovd immediately prior to loading and delivery of the lens.Do not attempt to load the lens without adequate ovd in the device.Not adequately filling the device with viscoelastic will result in inadequate coverage of lens and the lens fold path with ovd, which may result in damage.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Correction information was provided in h.6, a140801 product code, e2403 patient code and f27 health impact code was added.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: 21241413
• Report Number: 1119421-2025-00233
• Device Sequence Number: 14362602
• Product Code: HQL
• UDI-Device Identifier: 00380652552486
• UDI-Public: (01)00380652552486(17)280219(11)230221(10)15589154
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/09/2025

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 Model Number: MA60AC
• Device Catalogue Number: MA60AC.180
• Device Lot Number: 15589154
• 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: 01/02/2025
• Supplement Date Received by Manufacturer: 04/03/2025; 05/13/2025
• Initial Report FDA Received Date: 01/27/2025
• Supplement Report FDA Received Date: 05/01/2025; 06/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2023
• 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: CLAREON MONARCH IV IOL , INJECTOR.; DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE.; MONARCH II IOL, CARTRIDGE B.; MONARCH II LOADING FORCEPS.; SURGICAL PRODUCT, UNSPECIFIED.
• Patient Sex: Unknown