MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH ULTRASERT DELIVERY SYSTEM; INTRAOCULAR LENS

Model Number	ACU0T0
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional reported during a cataract and intraocular lens (iol) implant procedure, when loading/priming lens whole lens was twisted with no patient contact.The procedure was completed on same day with an unspecified new lens without any harm to the patient.
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 has been provided in d.9.,h.3., h.6., and h.11.The device with the lens was returned in a blister tray inside the carton.The lens stop and plunger lock were removed.The plunger was oriented correctly.Viscoelastic was dried in the device.The plunger was advanced to mid-nozzle and the plunger tip was in contact with the trailing optic edge.The lens was located at mid-nozzle and correctly folded.The leading haptic was correctly folded into the optic.The trailing haptic was misfolded, looped around the plunger tip.The haptic distal area was extended backward along the right side of the plunger with the distal tip oriented toward the loading area.Product history records were reviewed and the documentation indicated the product met release criteria.A non-qualified viscoelastic was indicated.The trailing haptic was observed to be misfolded, looped across the front of the plunger.This was most likely interpreted by the customer as the reported complaint.The root cause for the reported complaint may be related to a failure to follow the ifu (instructions for use).A non-qualified viscoelastic was indicated.The ifu instructs: during device preparation and implantation of the company preloaded delivery system, an 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).

• Brand Name: ACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH ULTRASERT DELIVERY SYSTEM
• Common Device Name: INTRAOCULAR LENS
• 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: 22213412
• Report Number: 1119421-2025-01680
• Device Sequence Number: 8132671
• Product Code: HQL
• UDI-Device Identifier: 00380652395199
• UDI-Public: (01)00380652395199(17)270617(11)240618(10)15877986
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2025

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: ACU0T0
• Device Lot Number: 15877986
• 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: 05/22/2025
• Supplement Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2024
• 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: NUVISC PRO 506009.
• Patient Sex: Unknown