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	Defective Component (2292); Failure to Advance (2524)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample device was 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 used device and the lens were returned loose in a large biohazard bag.The plunger lock and lens stop have been removed.The plunger was oriented correctly.Viscoelastic was observed in the device.The plunger was retracted prior to the fill line.There was no damage observed to the device.The plunger was removed and assessed.No damage was observed.The plunger was reinserted into the device with no abnormalities observed.The lens has solution observed dried on both surfaces.The optic has a short scrape mark near the edge on the anterior optic surface.The optic has additional light scratches on the anterior surface.A qualified viscoelastic was indicated.The root cause for the reported complaint cannot be determined.The used device and the lens were returned separately.Information was provided that indicated ¿shaft was over lens in the lens loader, pulled back to correct, but lens skewed and was not advanceable".The information suggests that a plunger override occurred.The observed scrape mark on the optic anterior surface may have occurred due to the reported plunger override.The method described of pulling back the plunger after the plunger went over the lens and the lens was "not advanceable" suggests a second attempt at delivery.This would not be a recommended practice.The instructions for use (ifu) instructs the user to gently advance the plunger in one smooth continuous motion to deliver the intraocular lens (iol).A qualified viscoelastic was indicated.Plunger override may occur: due to rapid advancement faster than the ifu recommend rate.If inadequate viscoelastic is placed in the device this will cause inadequate coverage of the lens fold path which may cause the lens to advance incorrectly or become ¿stuck¿ in the device allowing the plunger to override the lens.If the device is overfilled with ovd, this can prevent the trailing haptic from being placed properly or move the lens out of position resulting in misfolding.If the operating room temperature is too high (> 23°c / 73° f) lens folding consistency is negatively affected, the lens is more adherent and this may inhibit lens advancement.Any of the above listed causes alone, or in combination, may create the reported event.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A healthcare professional reported during an intraocular lens (iol) implant procedure, the shaft was over lens in the lens loader and lens skewed and was not advanceable.Additional information was requested.

• 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: 16500812
• Report Number: 1119421-2023-00409
• Device Sequence Number: 14984803
• Product Code: KYB
• UDI-Device Identifier: 00380652394482
• UDI-Public: 00380652394482
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/08/2023

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: 04/16/2024
• Device Model Number: AU00T0
• Device Lot Number: 15187771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2023
• Initial Report FDA Received Date: 03/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2021
• 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: DUOVISC VISCOELASTIC SYSTEM
• Patient Sex: Unknown