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

Model Number AU00T0

Device Problem Material Rupture (1546)

Patient Problem No Code Available (3191)

Event Date 06/27/2018

Event Type  Injury  

Manufacturer Narrative

The device was returned.The plunger is oriented correctly.Viscoelastic is observed in the device.The plunger has been retracted to mid-nozzle.The bottom of the plunger tip is bent.The nozzle was removed and cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results.The returned dvd was reviewed by qa and r&d.The device is brought into view and properly filled with viscoelastic.The lens is advanced at a proper rate to mid-nozzle, well short of the correct haptic inspection position.The leading haptic is extended.The trailing haptic is observed misfolded, looped across the plunger tip.The lens is advanced from mid-nozzle into the eye.The lens is advanced too rapidly from this point.The lens did not ¿shoot¿ out but appeared to be forced out by the plunger.Product history records were reviewed and the documentation indicated the product met release criteria.A qualified viscoelastic was indicated.Based on the dvd review the trailing was misfolded.This most likely caused increased resistance during delivery.The root cause for the misfolded trailing haptic cannot be determined.Haptic folding may be influenced by an intermittent plunger rate or if the operating room temperature is too high (> 23°c / 73° f).If the operating room temperature is too high lens folding consistency is negatively affected as the lens more adherent.This may inhibit lens advancement or contribute to incorrect haptic folding.A failure to follow the dfu was observed.The lens was initially advanced to mid-nozzle.The dfu instructs to advance the lens to the fill line.The lens was advanced too rapidly from the incorrect position into the eye.The misfolded trailing haptic was evident when the lens was at mid-nozzle.The dfu instructs: after the lens has been advanced to the nozzle line, the lens should be visually inspected to determine the position of the haptics.The plunger should be in contact with the trailing optic edge.After confirming the lens is properly positioned and the haptics are folded properly, proceed with lens implantation.Proceeding with implantation of a misfolded haptic or a lens that appears to be ¿out of position¿ can result in a broken haptic or other negative outcome.The force needed to push the lens out of the device is the most likely cause of the observed plunger damage.In addition, the dfu instructs to rotate the device when delivering a leading haptic configuration.By rotating the device, the leading haptic would have had a better chance to conform to the curvature of the bag.There are no other complaints in the lot.Additional information was requested.The manufacturer internal reference number is: (b)(4).

Event Description

A surgeon reported that during an intraocular lens (iol) implant procedure the lens shot out of the device and ruptured the posterior capsular bag.The leading haptic was extended during the lens injection.The lens remains implanted with the optic in the bag, but a haptic out of the bag due to the rupture.The surgeon blames the event on the device.The surgeon did not indicate further plans of intervention.

Manufacturer Narrative

This supplement is being filed to correct the value to adverse event and product problem.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, LTD. - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LTD. - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: bryan blake ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7720843
• MDR Text Key: 115060744
• Report Number: 1119421-2018-01011
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Model Number: AU00T0
• Device Lot Number: 12584943
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR