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

Model Number	MA60AC
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/24/2025
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 non health care professional reported as during delivery of the lens to the eye, the haptic came off, there was patient contact, procedure completed on the same day.Additional information has been requested.
Additional Manufacturer Narrative
Additional information has been provided in h.3., h.6., and h.11.The product was not returned.A photo was provided that shows the lens loose in the opened lens pouch.One haptic appears broken at the insertion point.The lens case is not visible in the photo.Product history records were reviewed and the documentation indicated the product met release criteria.The account indicated the use of a non-qualified cartridge.The company lens model is only qualified for use in the company (a) and (b) cartridges.A handpiece was indicated with is qualified for use with this lens, with the use of qualified lens/cartridge combinations.A non-qualified viscoelastic was indicated.Based on our observation of the attached photo, the haptic is broken.The product has not been received to evaluate.The root cause is most likely related to a failure to follow the ifu (instructions for use).The account used an unqualified lens/cartridge/viscoelastic combination.Company foldable iol (intraocular lens) are qualified for use with a company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The use of an unqualified combination may cause damage to the iol and potential complications during the implantation process.It is difficult to make a determination of handling / damage without evaluation of the physical sample.Haptic manufacturing is a validated process with multiple inspections to verify the quality of the produced haptic material.These inspections include a verification of the dimensional accuracy, tensile strength, flexibility and cosmetic appearance.The inspections ensure that the material meets all required specifications before it is allocated for use.Due diligence has been performed in an attempt to obtain further information on this event.File will be reopened if new information or the sample 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: 21876199
• Report Number: 1119421-2025-01120
• Device Sequence Number: 20808237
• Product Code: HQL
• UDI-Device Identifier: 00380652552585
• UDI-Public: (01)00380652552585(17)250811(11)200812(10)15087883
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2025

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 Expiration Date: 08/11/2025
• Device Model Number: MA60AC
• Device Catalogue Number: MA60AC.230
• Device Lot Number: 15087883
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/27/2025
• Supplement Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 06/13/2025
• Date Device Manufactured: 08/12/2020
• 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: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Patient Sex: Unknown