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	Break (1069); Failure to Deliver (2338); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample device 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).
Event or Problem Description
A nurse reported that during an intraocular lens (iol) implant procedure, it was noted that the lens was stuck up on plunger tip during delivery resulting to broken haptics.The procedure was completed on the same day.Broken iol was not implanted.There was no patient contact.Additional information has been requested.
Additional Manufacturer Narrative
Additional information provided in h.3., h.6.And h.11.The device was not returned.Photos were provided.The first photo showed the device being held by an ungloved hand.The view was from mid-barrel to the tip.The plunger had been fully advanced outside the nozzle tip.The plunger was oriented correctly.A broken haptic was visible on top of the plunger at the nozzle entry area.The haptic tip was oriented toward the loading bay.The second photo was of the draped eye at two different magnifications.The eye was also clamped.The plunger of the device had been advanced outside of the nozzle tip and was pressed to the outside of the top of the eye at the clamp.A pair of forceps were visible holding the plunger tip.What may be the lens was visible on the eye to the left of the clamp.The third photo was of the carton endcap.Product history records were reviewed and documentation indicated the product met release criteria.Viscoelastic was not provided.It is unknown if a qualified viscoelastic was used.Based on review of the provided photos, the haptic was broken.The broken haptic was on top of the plunger at the nozzle entry area.The plunger had been fully advanced outside of the nozzle.The trailing haptic position may indicate it was not in a proper position for advancement per the provided diagrams in the instructions for use (ifu).The ifu instructs: after the lens has been advanced to the ¿fill-to¿ line, the lens should be visually inspected to determine the position of the haptics.The plunger should be in contact with the trailing optic edge.No part of the lens should exit the nozzle prior to insertion through the incision.Once the lens is in position at the ¿fill-to¿ line, it should be implanted within 3 minutes.Proceeding with implantation of a misfolded haptic or a lens that appears to be ¿out of position¿ can result in a broken haptic or other negative outcome, since the haptic may be trapped and stretched, and/or pinched and sheared by the moving plunger.The ifu instructs: during device preparation and implantation of the company 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.File will be reopened if new information is received.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been received and stated the plunger over-ride was noticed.There was patient contact.Procedure was completed with another company lens.
Additional Manufacturer Narrative
Additional information provided in a.1., a.2., a.3.A., a.4., d.5., b.5.And h.6.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; 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: 21854217
• Report Number: 1119421-2025-01071
• Device Sequence Number: 12922202
• Product Code: KYB
• UDI-Device Identifier: 00380652394833
• UDI-Public: (01)00380652394833(17)261030(11)231101(10)15743939
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/19/2025

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: 15743939
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/21/2025
• Supplement Date Received by Manufacturer: 06/03/2025; 07/29/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 06/24/2025; 08/19/2025
• Date Device Manufactured: 11/01/2023
• 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
• Patient Sex: Unknown