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	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device with the lens was returned loose in the opened carton.The plunger lock and lens stop have been removed.Viscoelastic was observed in the device.The plunger was retracted to mid-nozzle.The lens appeared to have been replaced into the device loading area on top of the plunger.One haptic was folded onto the anterior optic surface and dried in viscoelastic.The other haptic distal tip has become broken in the closing of the door.There was no damage 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 stuck to incision".The lens appeared to have been replaced into the device loading area on top of the plunger for return.The plunger of the used device was retracted to mid-nozzle.The position of the plunger relative to the lens during delivery cannot be determined.The ifu(instructions to follow) instructs: after the lens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.No device damage was observed.A qualified viscoelastic was indicated.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non healthcare professional reported that during implantation of an intraocular lens (iol) the lens stuck to incision/wound.There was patient contact.Additional information was received stating the patient was not hospitalized for the event and there was no patient harm.

• 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: 13677804
• Report Number: 1119421-2022-00406
• Device Sequence Number: 4894073
• Product Code: KYB
• UDI-Device Identifier: 00380652394918
• UDI-Public: 00380652394918
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/07/2022

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: 04/19/2024
• Device Model Number: AU00T0
• Device Lot Number: 15187565
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2022
• Initial Report FDA Received Date: 03/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2021
• 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