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

Model Number AU00T0

Device Problem Stretched (1601)

Patient Problem Corneal Abrasion (1789)

Event Date 02/26/2022

Event Type  Injury  

Event Description

A nurse reported that, during intraocular lens implant procedure, the plunger went with leading haptic sticking out and there was a slight scratch on endothelium.Additional information was received that, the iol remained in patient's eye.

Manufacturer Narrative

A sample device was not returned for analysis.Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The product was not returned for analysis.A qualified viscoelastic was indicated.The root cause for the reported issue could not be determined.The lens remains implanted.Straight leading haptics are not a product malfunction.The instructions for use (ifu) has instructions related to a straight leading haptic, which is an acceptable position.The ifu instructs if the leading haptic is straight or looped and extended in front of the lens, rotate device clockwise to be bevel left before advancing plunger to ensure the leading haptic is correctly placed in the capsular bag.As the leading haptic begins to exit the nozzle tip, place the leading haptic into the capsular bag in its correct orientation, and continue to slowly advance the plunger to deliver the lens.As the optic exits the nozzle, rotate the device counter clockwise back to center or slightly bevel right if needed to ensure the lens unfolds anterior side up within the capsular bag.The manufacturer internal reference number is: (b)(4).

• 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: 13894080
• MDR Text Key: 288041307
• Report Number: 1119421-2022-00570
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AU00T0
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PROVISC
• Patient Outcome(s): Other