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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	03/24/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The used device and the lens were returned inside a self sealing non company blue pouch in a biohazard bag.The plunger lock and lens stop were removed.The plunger was oriented correctly.Viscoelastic was observed in the device.The plunger was retracted to mid-nozzle.There was no damage observed to the device.The lens was scraped.The optic was cut into two portions, typical in appearance to damage created to facilitate removal from the eye.A qualified viscoelastic was indicated.The product investigation could not identify a root cause for the reported complaint.The removed lens and the used device were returned.It is unknown if the product contributed to the event.No damage was observed to the device.The plunger was retracted.The plunger position in relation to the lens during advancement cannot be determined.It cannot be confirmed if the lens was in a proper position for advancement during delivery.Information was provided in the file that the 18.0 diopter lens was removed and replaced with an another company model 18.0 diopter lens.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 capsule tear was noted after lens was implanted.The lens was removed and replaced with another lens.The capsular bag was not intact.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: 14201639
• Report Number: 1119421-2022-00843
• Device Sequence Number: 1778302
• Product Code: KYB
• UDI-Device Identifier: 00380652394727
• UDI-Public: 00380652394727
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 04/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/05/2024
• Device Model Number: AU00T0
• Device Lot Number: 15318269
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2022
• Initial Report FDA Received Date: 04/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2021
• 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: DISCOVISC; ORA SYSTEM
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male