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 Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A health care professional reported that during an intraocular lens (iol) implant procedure, it was noted that the lens trailing haptic folded wrong, feet came first, did not come out of shooter.Hence the lens was taken from the injector and put in another shooter and was implanted.Additional information has been received and stated that the incorrect position of the lens in the cartridge.There was no patient harm.
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.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
There are eight medical device reports associated with this report.This file is 5 of 8.Additional information has been received and stated that there was no patient contact.
Additional Manufacturer Narrative
Correction information was provided in 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: 21959029
• Report Number: 1119421-2025-01278
• Device Sequence Number: 9198019
• Product Code: KYB
• UDI-Device Identifier: 00380652394772
• UDI-Public: (01)00380652394772(17)261011(11)231013(10)15734512
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 06/30/2025

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: 15734512
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/07/2025
• Supplement Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 06/30/2025
• Date Device Manufactured: 10/13/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PROVISC.
• Patient Sex: Unknown