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	09/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Additional information has been received and stated that the incident occurred during loading.There was no patient contact.
Additional Manufacturer Narrative
Additional information was provided in b.5.The manufacturer internal reference number is: (b)(4).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Additional Manufacturer Narrative
Additional information has been received and indicated that loading difficulties during loading with confirmed no patient contact.Based on this information this event no longer meets reporting criteria per applicable regulation, because there is no evidence of a life threatening injury/illness or permanent impairment/damage, there has been no medical or surgical intervention to preclude permanent impairment/damage and the information provided does not represent a product problem that is likely to cause the above-mentioned events if the product problem were to recur.The event is understood as being associated with priming the device and is considered prior to use.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A nurse reported with a description of loading difficulties with defective lenses was encountered for the intraocular lenses.The lenses were not implanted and were replaced.The patient was not affected.Additional information has been requested.There are two medical device reports associated with this report.This is 1 of 2.
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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• 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: 23485821
• Report Number: 1119421-2025-02863
• Device Sequence Number: 16091737
• Product Code: HQL
• UDI-Device Identifier: 00380652395359
• UDI-Public: (01)00380652395359(17)280602(11)250604(10)16053555
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 01/22/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: ACU0T0
• Device Lot Number: 16053555
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/17/2025
• Supplement Date Received by Manufacturer: 12/16/2025; 01/08/2026
• Initial Report FDA Received Date: 11/06/2025
• Supplement Report FDA Received Date: 01/07/2026; 01/22/2026
• Date Device Manufactured: 06/04/2025
• 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