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 Damaged by Another Device (2915); Failure to Eject (4010)
Health Effect - Clinical Codes	Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A non healthcare professional reported during an intraocular lens implant procedure, the lens shot out and the haptic appeared to be bent over the lens.The lens was not used.Additional information has been requested.
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.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The lens and the used device were returned separately inside the opened product carton.The lens was returned inside a small plastic bag.Viscoelastic was dried on the lens.One haptic was adhered in the dried solution onto the anterior optic surface.The used device was returned inside the opened blister tray.The lens stop and plunger lock were removed.The plunger was oriented correctly.Viscoelastic was observed inside the device.The plunger was fully deployed.The plunger tip extended beyond the nozzle tip.No damage was observed to the device.Product history records were reviewed and documentation indicated the product met release criteria.A qualified viscoelastic was indicated.The root cause cannot be determined for the reported complaint of "lens shot out and the haptic appeared to be bent over the lens".The lens and the device were returned separately.The reported bent haptic was observed.The plunger in the device was fully deployed.No damage was observed to the device.A qualified viscoelastic was indicated.Due to being returned separately, it cannot be confirmed if the position of the lens and plunger were in the acceptable positions for advancement.The position of the plunger relative to the lens during delivery cannot be determined.The ifu instructs: after the lens has been advanced to the nozzle 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.After confirming the lens is properly positioned and the haptics are folded properly, proceed with lens implantation.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.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; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 14141960
• Report Number: 1119421-2022-00792
• Device Sequence Number: 12325653
• Product Code: KYB
• UDI-Device Identifier: 00380652394734
• UDI-Public: 00380652394734
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2022

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 Expiration Date: 07/14/2024
• Device Model Number: AU00T0
• Device Lot Number: 15234137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2022
• Supplement Date Received by Manufacturer: 05/04/2022
• Initial Report FDA Received Date: 04/19/2022
• Supplement Report FDA Received Date: 05/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Patient Sex: Unknown