MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM; LENS, GUIDE, INTRAOCULAR

Model Number AU00T0

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Capsular Bag Tear (2639)

Event Date 03/24/2022

Event Type  Injury  

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lock and lens stop were removed.The plunger was oriented correctly.Viscoelastic was observed in the device.The plunger was retracted to mid-nozzle.There was no damage observed to the device.The lens was scraped.The optic was cut into two portions, typical in appearance to damage created to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were returned.It is unknown if the product contributed to the event.No damage was observed to the device.The plunger was retracted.The plunger position in relation to the lens during advancement cannot be determined.It cannot be confirmed if the lens was in a proper position for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 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
• Type of Device: 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
• MDR Text Key: 290041960
• Report Number: 1119421-2022-00843
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 00380652394727
• UDI-Public: 00380652394727
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AU00T0
• Device Lot Number: 15318269
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2022
• Date Manufacturer Received: 04/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DISCOVISC; ORA SYSTEM
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male