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

Model Number AU00T0

Device Problems Unintended Ejection (1234); Activation, Positioning or Separation Problem (2906)

Patient Problems Rupture (2208); Rupture (2208); Capsular Bag Tear (2639)

Event Date 03/04/2019

Event Type  Injury  

Manufacturer Narrative

The device was received by a company representative and is in transit to the manufacturing site for investigation.Investigation including root cause analysis will be completed.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56.When additional reportable information becomes available.Product history records were reviewed and documentation indicated the product met release criteria.There are no other complaints in the lot.The manufacturer internal reference number is: (b)(4).

Event Description

A surgeon reported that during an intraocular lens (iol) procedure, the lens shot out of the injector and ruptured the posterior capsular wall.The lens was grabbed with forceps, cut up and removed from the eye.An anterior vitrectomy was performed.A back up 3 piece lens was implanted instead.Additional information was requested.

Manufacturer Narrative

The device and the lens were returned.The plunger is oriented correctly.Inadequate viscoelastic is observed in the device.The plunger has been retracted to mid-nozzle.No damage is observed.The lens cut into two pieces and taped to a piece of gauze.The lens was cleaned with lphse to remove from the tape.The optic is scratched on the anterior surface.The nozzle was removed and cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results.A video of the surgery was provided.The device tip comes into view as it is inserted into the incision.The lens is advanced to the fill line.The leading haptic is tucked in the optic fold.As the lens advances the plunger can be seen shifted to the right and appears to have underriden the optic.The lens is rotated to the right.The trailing haptic appears to be misfolded under the optic.Force is applied to advance the lens.The lens abruptly enters the eye.R&d also reviewed the video.There lens should have looked abnormal if inspected prior to patient contact.There must have been an increased level of plunger resistance as well.This should have been a detectable misfold at the haptic check position.The root cause for the reported issue may be related to a failure to follow the dfu.A non-qualified viscoelastic was indicated.Material properties of non-qualified ovds may contribute to underfill, overfill, misfolding of the haptics, or other inconsistent folding outcomes.As stated in the dfu, only qualified viscoelastics must be used in conjunction with the device.All other viscoelastics are not qualified for use.Lens delivery performance may be negatively affected when using other non-qualified viscoelastics leading to lens delivery issues and /or damage.The use of non-qualified viscoelastics is considered a failure to follow the dfu.Based on the provided video review, the lens was not in a proper position for advancement.There appeared to be a plunger underride and a misfolded trailing haptic.This should have been detectable at the recommended inspection step.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.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: 8456678
• MDR Text Key: 140118751
• Report Number: 1119421-2019-00366
• Device Sequence Number: 0
• Product Code: KYB
• 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: 06/25/2019
• 2 Devices were Involved in the Event: 1 2

2 Patient was Involved in the Event

• Date FDA Received: 03/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: AU00T0
• Device Lot Number: 12492692
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 0
• Patient Outcome(s): Other
• Patient Age: 58 YR