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

Model Number AU00T0

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/16/2019

Event Type  malfunction  

Manufacturer Narrative

A sample device was not returned, but a video was returned.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.The video analysis including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A customer reported that during an intraocular lens (iol) implant procedure, a haptic was torn while attempting implanting.The iol got stuck in the incision, and when it was forcibly progressed, the injector came off the incision, and the haptic was broken.The surgery was completed after replacing the product with another one.Additional information was requested.

Manufacturer Narrative

The device was returned.Viscoelastic is observed in the device.The plunger has been retracted.The delivered lens has been placed back in the loading area.The broken haptic is observed in the nozzle tip.The haptic is oriented toward the end of the tip.A video of the delivery was provided.The delivery was reviewed.The reported broken haptic was observed.Based on review of the device and the provided video the root cause appears to related to a failure to follow the dfu.The video showed that the nozzle tip was not inserted far enough into the incision.The lens was advanced from behind the fill line.The dfu instructs to gently advance the plunger in one smooth continuous motion after inspection of the lens at the fill line.The dfu also instructs to maintain adequate pressure to ensure the nozzle tip remains in the incision.The lens advancement was stopped before the lens was delivered.Due to the loss of the counter traction, the eye moves away as the lens pushes against it.When the counter traction is lost, the device moves back away from the eye as the plunger is advanced slightly.This leaves none or almost none of the nozzle tip in the incision.The initial and final position of the device tip (after the move backwards), and the stop in the plunger advancement, all allow the optic to open in the incision.Then the plunger is not advanced far enough to allow the trailing haptic to clear the nozzle.The device is lifted up and away from the lens in the incision, and this action breaks the trailing haptic as it has not released from the device.A non-qualified viscoelastic was indicated.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
• MDR Report Key: 9579223
• MDR Text Key: 179272372
• Report Number: 1119421-2020-00070
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 02/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: AU00T0
• Device Lot Number: 12709662
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Date Manufacturer Received: 02/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OPELEAD