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

Model Number	MN60MA
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.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 nurse reported that following an intraocular lens (iol) implant procedure, during general recheck, surgeon observed that one haptic was entrapped in anterior chamber.Patient was scheduled for either reposition or replacement of lens.Patient chose to have lens replaced with another brand iol.Additional information has been requested.
Event or Problem Description
Additional information has been received that the lens was explanted and exchanged with non-company lens 5 years 3 months following the initial procedure.There was no patient impact.
Additional Manufacturer Narrative
Additional information provided in a.1., a.2., a.3.A., b.2., b.3., b.5., b.6., b.7., d.5., d.6.A., d.6.B., d.10.And h.6.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Corrected information provided in b.5.And h.6.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Patient also underwent lasik and lag surgery.There was no patient impact.

• 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: 23671646
• Report Number: 1119421-2025-03041
• Device Sequence Number: 18580439
• Product Code: HQL
• UDI-Device Identifier: 00380655095461
• UDI-Public: (01)00380655095461(17)240229(11)190314(10)12688999
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/27/2026

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: 02/29/2024
• Device Model Number: MN60MA
• Device Catalogue Number: MN60MAN010
• Device Lot Number: 12688999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/05/2025
• Supplement Date Received by Manufacturer: 12/10/2025; 01/05/2026
• Initial Report FDA Received Date: 11/28/2025
• Supplement Report FDA Received Date: 01/02/2026; 01/27/2026
• Date Device Manufactured: 03/14/2019
• 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: AMVISC.; MONARCH II CARTRIDGE B.; MONARCH III INJECTOR.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female