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

Model Number AU00T0

Device Problem Difficult to Advance (2920)

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

Event Date 11/19/2018

Event Type  malfunction  

Manufacturer Narrative

A sample device was not returned for analysis.Product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There are no other complaints in the lot.Additional information was requested.The manufacturer internal reference number is: (b)(4).

Event Description

A materials manager reported that during an intraocular lens (iol) implant procedure, the lens was noted to be hard to advance.There was no patient contact.Additional information was requested.

Manufacturer Narrative

The device with the lens was returned loose in the carton.The lens stop and plunger lock were removed.The plunger is oriented correctly.Inadequate viscoelastic was observed in the device.The plunger has advanced the lens to mid-nozzle and underrode the optic trailing portion.The trailing optic edge is broken and folded under the optic.The leading haptic is extended into the tip.The trailing haptic is looped across the front of the plunger tip and extended backward along the right side.The nozzle was removed and cleaned for further evaluation.The lens was removed during cleaning.Top coat dye stain testing was conducted with acceptable results.A qualified viscoelastic was indicated.A plunger underride was observed.The optic is misfolded up and the trailing haptic was observed to be misfolded, looped across the front of the plunger.This evidence supports the complaint of "hard to advance".The root cause may be related to a failure to follow the dfu.Inadequate viscoelastic was observed in the device.The dfu instructs: fill the device until viscoelastic can be observed flowing to the line on the nozzle tip.This will require approximately 0.2 ml of viscoelastic.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.The manufacturer internal reference number is: (b)(4).

Event Description

Upon receipt of the returned sample, it became evident that the facility had reported the back up product data instead of the complaint product data.Data was updated.

Manufacturer Narrative

The product was returned for analysis.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.Regarding the updated lens data, results from the product history record review indicated the product met release criteria.There have been no other complaints reported in the lot number.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
• MDR Report Key: 8194899
• MDR Text Key: 131376327
• Report Number: 1119421-2018-01789
• 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,Followup
• Report Date: 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: AU00T0
• Device Lot Number: 12614400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Date Manufacturer Received: 02/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: VISCOAT