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 Difficult to Setup or Prepare (1487); Failure to Advance (2524); Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2025
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 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 unspecified shooter and was implanted.Additional information has been requested, received and stated that in the surgeon opinion, incorrect position of the lens in the cartridge caused the event.There was no patient contact.
Additional Manufacturer Narrative
Correction information provided in h.6.(fda product problem code a150204 missed to capture in initial report).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 1 of 8.
Additional Manufacturer Narrative
Correction information provided in b.5.And h.6.(fda product problem code a150202 was removed).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 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: 21959804
• Report Number: 1119421-2025-01282
• Device Sequence Number: 18454721
• Product Code: KYB
• UDI-Device Identifier: 00380652394796
• UDI-Public: (01)00380652394796(17)261028(11)231030(10)15743874
• 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,Followup
• Report Date (Section B): 07/10/2025

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: 15743874
• 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: 05/27/2025; 06/17/2025
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 06/17/2025; 07/10/2025
• Date Device Manufactured: 10/30/2023
• 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 OPHTHALMIC VISCOSURGICAL DEVICE.; UNSPECIFIED SHOOTER.
• Patient Sex: Unknown