MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. ACRYSOF IQ TORIC SINGLEPIECE IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	SN6AT4
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information was provided in d.9., h.3., h.6.And h.11.The product was returned for analysis and damage was observed to the intraocular lens (iol).No cartridge was returned.Iol returned positioned incorrectly in the lens case.Solution is dried on the iol.One haptic is broken/torn and not returned, the other haptic is intact.The optic is scratched/marked-rejectable with loose fibers & particulate.No cartridge returned.We are unable to determine the root cause for the reported complaint trailing haptic trapped between plunger and cartridge, haptic broken.The reported damage occurred at the time of iol went out of the cartridge.No cartridge was returned; due to this, we are unable to complete a thorough investigation to determine a root cause.In addition to this, all iols are 100 percent cosmetically inspected as per approved manufacturing procedures and the observed lens condition would not meet our current release criteria.Based on these investigation findings, we are unable to verify if the iol contributed to the event.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A healthcare professional reported that during cataract surgery with an intraocular lens (iol) implant procedure, the lens was loaded successfully into cartridge.When lens was injecting into the eyes, the trailing haptic trapped in between the plunger and cartridge, caused the haptic broken.There was no patient contact with the product.Another back up lens used to complete the surgery without complication.Additional information has been requested.
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 TORIC SINGLEPIECE IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 20513137
• Report Number: 9612169-2024-01053
• Device Sequence Number: 20956692
• Product Code: MJP
• UDI-Device Identifier: 00380652250290
• UDI-Public: (01)00380652250290(17)240930(11)191007(10)21255105(21)21255105037
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/24/2025

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: 09/30/2024
• Device Model Number: SN6AT4
• Device Catalogue Number: SN6AT4.135
• Device Lot Number: 21255105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/23/2024
• Supplement Date Received by Manufacturer: 10/24/2024; 01/28/2025
• Initial Report FDA Received Date: 10/23/2024
• Supplement Report FDA Received Date: 11/21/2024; 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2019
• 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: MONARCH III IOL CARTRIDGE D; MONARCH III IOL INJECTOR
• Patient Age: 65 YR
• Patient Sex: Female