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

Model Number	MA60AC
Medical Device Problem Code	Optical Decentration (1360)
Health Effect - Clinical Codes	Zonular Dehiscence (2698); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2024
Type of Reportable Event	Serious Injury
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's internal reference number is: (b)(4).
Event or Problem Description
A healthcare professional reported with a description of intraocular lens decentered after implantation but ended up with zonularlysis.No patient harm was reported.Additional information has been received and stated that the cause of the lens decentering should be manipulation stress causing weak zonule but not sure whether stress from iol or patient factor.
Event or Problem Description
The intraocular lens was removed during initial procedure.
Additional Manufacturer Narrative
Correction: on initial mdr the imdrf health impact code of f1905 was missed.It should have been submitted in the initial mdr.Correction information was provided in h.11.Additional information was provided in b.5., h.3., h.6.And h.11., d.9.The lens was returned for evaluation.Solution and blood are dried on the lens.One haptic is bent in the gusset area.The opposite haptic has been pulled out of the haptic insertion area and returned loose in the lens case.The pulled out haptic has a bulbous area which is indicative that a weld was performed during the manufacturing process.Product history records were reviewed and the documentation indicated the product met release criteria.The file indicates the use of a qualified cartridge and handpiece.The file also indicates the use of a non qualified viscoelastic.The product investigation could not identify a root cause for the reported complaint.Information was provided that it should be manipulation stress causing weak zonule but not sure whether stress from iol or patient factor.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information was provided in b.5., and d.10.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been received and stated that the procedure was completed with the same company model lens.

• Brand Name: ACRYSOF MULTIPIECE IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 20758044
• Report Number: 1119421-2024-02292
• Device Sequence Number: 12929476
• Product Code: HQL
• UDI-Device Identifier: 00380652552523
• UDI-Public: (01)00380652552523(17)270330(11)220401(10)15381940
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/11/2025

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 Model Number: MA60AC
• Device Catalogue Number: MA60AC.200
• Device Lot Number: 15381940
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/24/2024
• Supplement Date Received by Manufacturer: 01/14/2025; 03/13/2025
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 02/09/2025; 04/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2022
• 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 , CARTRIDGE B; MONARCH II IOL, CARTRIDGE B; MONARCH III IOL , INJECTOR; MONARCH III IOL, INJECTOR
• Outcome Attributed to Adverse Event: Other
• Patient Age: 56 YR
• Patient Sex: Female