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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2025
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)(6).
Event or Problem Description
A nurse before surgery noticed that the lens haptic breakage.So they have replaced with a new product and performed surgery without harm to the patient.
Additional Manufacturer Narrative
Additional information has been provided in b.5., d.9., h.3., h.6., and h.11.The lens was returned for evaluation.Solution is dried on the lens.One haptic is broken in the haptic insertion area and returned loose in the lens case.The opposite haptic is extending out of the lens case base in the locking mechanism area.The optic has been cut in half.Damage is observed to the locking mechanism area on the lens case base with a peg broken off the lens case lid.Product history records were reviewed and the documentation indicated the product met release criteria.Broken haptic damage was observed.Information in the file states the damage was found after the lens was picked up with forceps but before loading into a cartridge.All lenses are 100 percent inspected for cosmetic attributes and the damage exhibited by the returned complaint sample would not have met company release criteria.Based on our observation, it can be reasonably concluded that the damage is not manufacturing related.Due to the presence of surgical solution and the condition of the returned sample, the damage is most likely related to customer handling.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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information received and it states that the lens haptic break was found while loading, not when it was opened.Forceps was used because it was discovered before using cartridges, handpieces, and viscoelastic.

• 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: 21864042
• Report Number: 1119421-2025-01091
• Device Sequence Number: 17291159
• Product Code: HQL
• UDI-Device Identifier: 00380652552578
• UDI-Public: (01)00380652552578(17)280104(11)230106(10)15562800
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2025

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.225
• Device Lot Number: 15562800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/21/2025
• Supplement Date Received by Manufacturer: 06/04/2025
• Initial Report FDA Received Date: 04/18/2025
• Supplement Report FDA Received Date: 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2023
• 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: REPLACED WITH UNSPECIFIED LENS
• Patient Sex: Unknown