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

Model Number	SN60WF
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Capsular Bag Tear (2639); Zonular Dehiscence (2698)
Date of Event	09/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information provided in 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 and adhered to the optic by solution.The optic is broken and split on one side.Product history records were reviewed and the documentation indicated the product met release criteria.Qualified associated products were indicated.The product investigation could not identify a root cause for the reported complaint.The file indicates the cause of the capsule rupture was zonularlusis.The lens was replaced with a sulcus lens.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A healthcare professional reported that during an intraocular lens (iol) implantation procedure, posterior capsule ruptured with zonulolysis was noticed.Subsequently, it was removed during initial procedure and procedure was completed with another lens.Additional information was requested and received stating that in surgeons opinion surgeon was unsure whether its related to iol or anatomy.
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).

• Brand Name: ACRYSOF IQ NATURAL SINGLEPIECE 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: 20759006
• Report Number: 1119421-2024-02301
• Device Sequence Number: 18457568
• Product Code: HQL
• UDI-Device Identifier: 00380655093306
• UDI-Public: (01)00380655093306(17)280617(11)230620(10)15667163
• 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
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.255
• Device Lot Number: 15667163
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/24/2024
• Supplement Date Received by Manufacturer: 02/14/2025
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 03/12/2025
• Date Device Manufactured: 06/20/2023
• 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: DISCOVISC OVD; MONARCH III IOL CARTRIDGE D; MONARCH III IOL INJECTOR
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown