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

Model Number AU00T0

Device Problem Malposition of Device (2616)

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

Event Date 12/31/2019

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: investigation 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.The manufacturer internal reference number is: (b)(4).

Event Description

A customer reported during the implant of an intraocular lens (iol) using a preloaded delivery system, the plunger went over the lens.There was contact with the patient and the procedure was completed the same day.Additional information was requested.

Manufacturer Narrative

The device with the lens was returned in the opened blister tray inside the opened carton.The plunger lock and lens stop have been removed.The plunger is oriented correctly.Viscoelastic is observed in the device.The plunger has advanced the lens to the fill line and has underrode the trailing and right side of the lens.The plunger is advanced toward the right side in the device.The right side of the optic is lifted onto the plunger and the remaining optic extends toward the left side in the device.The trailing haptic is looped around the plunger tip.The leading haptic is misfolded onto the optic and bent forward with the distal haptic tip oriented toward the nozzle tip.The nozzle was cleaned for further evaluation.The lens was removed during cleaning.Top coat dye stain testing was conducted with acceptable results.All product and batch history records are quality reviewed prior to product release.A qualified viscoelastic was used.A plunger underride was observed.This may have been interpreted as the reported complaint.The product investigation could not identify a root cause.A qualified viscoelastic was used.Plunger underride may occur: due to rapid advancement faster than the dfu recommend rate.Due to the use of a non-qualified viscoelastic.Material properties of non-qualified ovds may contribute to underfill, overfill, misfolding of the haptics, or other inconsistent folding outcomes.If inadequate viscoelastic is placed in the device this will cause inadequate coverage of the lens fold path which may cause the lens to advance incorrectly or become ¿stuck¿ in the device allowing the plunger to underride the lens.If the device is overfilled with ovd, this can prevent the trailing haptic from being placed properly or move the lens out of position resulting in misfolding.If the operating room temperature is too high (> 23°c / 73° f) lens folding consistency is negatively affected, the lens is more adherent and this may inhibit lens advancement.Any of the above listed causes alone, or in combination, may create the reported event.Top coat dye stain testing was conducted with acceptable results.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: 9665040
• MDR Text Key: 181931385
• Report Number: 1119421-2020-00174
• 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: other
• Type of Report: Initial,Followup
• Report Date: 04/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: AU00T0
• Device Lot Number: 12744718
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2020
• Date Manufacturer Received: 03/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED VISCOAT OVD, 000452, BEL.