MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM; LENS, GUIDE, INTRAOCULAR

Model Number	AU00T0
Medical Device Problem Codes	Device Damaged by Another Device (2915); Failure to Eject (4010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional reported during intraocular lens implant procedure the surgeon tried to advance the lens but plunger had pierced the lens.Additional information has been received and stated that there was no patient contact.
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).
Additional Manufacturer Narrative
Additional information was provided in d.9., h.3., h.6.And h.11.The device with the lens was returned.The plunger lock and lens stop have been removed.The plunger was oriented correctly.Inadequate viscoelastic was observed in the device.The plunger has been advanced under the lens to mid nozzle.The lens was on top of the plunger still in the loading area with the leading haptic partially into the nozzle entry area.The optic has a large deep scrape mark near the center on the posterior side of the lens in the travel path of the plunger.The provided photo matches the returned sample.Product history records were reviewed and the documentation indicated the product met release criteria.The file indicated the use of a non qualified viscoelastic.A plunger underride and lens damage were observed.The root cause of the reported complaint may be related to a failure to follow the instructions for use (ifu).A non qualified viscoelastic was used in the device.The ifu instructs during device preparation and implantation of the company iq iol with the company preloaded delivery system, a company qualified ophthalmic viscoelastic device (ovd) should be used.The use of an unqualified ovd may cause damage to the lens and potential complications during the device preparation and implantation steps.Inadequate viscoelastic was observed in the device.The ifu instructs fill the device until viscoelastic can be observed flowing to the line on the nozzle tip.This will require approximately 0.2 ml of viscoelastic.If inadequate viscoelastic is placed in the device this will cause inadequate coverage of the lens fold path which may cause the lens to advance incorrectly or become stuck in the device allowing the plunger to underride the lens.Plunger underride may occur due to rapid advancement faster than the ifu recommend rate.Due to the use of a non-qualified viscoelastic.Material properties of non qualified ovds may contribute to underfill, overfill, misfolding of the haptics, or other inconsistent folding outcomes.If inadequate viscoelastic is placed in the device, this will cause inadequate coverage of the lens fold path which may cause the lens to advance incorrectly or become stuck in the device allowing the plunger to underride the lens.If the device is overfilled with ovd, this can prevent the trailing haptic from being any of the above listed causes alone, or in combination, may create the reported event.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM
• Common Device Name: LENS, GUIDE, INTRAOCULAR
• 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: 20863647
• Report Number: 1119421-2024-02397
• Device Sequence Number: 8831405
• Product Code: KYB
• UDI-Device Identifier: 00380652394826
• UDI-Public: (01)00380652394826(17)270205(11)240207(10)15796259
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2025

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: AU00T0
• Device Lot Number: 15796259
• 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: 11/08/2024
• Supplement Date Received by Manufacturer: 01/17/2025
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 02/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2024
• 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: BIOLON. LOT, X10314AA.
• Patient Age: 73 YR
• Patient Sex: Female