MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH ULTRASERT DELIVERY SYSTEM; LENS, GUIDE, INTRAOCULAR

Model Number ACU0T0

Device Problem Defective Device (2588)

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

Event Date 03/17/2020

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.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).

Event Description

A facility representative reported that during an intraocular lens (iol) implantation procedure, the injector was messed up while in contact with the patient.The procedure was completed.Additional information was provided indicating at the injector did not push the lens forward.

Manufacturer Narrative

Additional information was provided in h.3., h.6.And h.10.Evaluation summary: the device with the lens was returned.The plunger is oriented correctly.Inadequate viscoelastic is observed in the device.The plunger has been retracted to the loading area.The lens appears to have been placed back in the loading area for return.The lens is posterior surface up with a broken haptic.The broken haptic was not in the device.The bottom plunger flange is bent backwards.This may indicate a plunger override occurred.The nozzle was removed and cleaned for further evaluation.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 indicated.The reported event could not be verified because the product was not returned in the reported condition.The root cause for the reported event may be related to a failure to follow the directions for use.Plunger damage was observed, which may indicate a plunger override occurred.Inadequate viscoelastic was observed in the device.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH 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: 9943969
• MDR Text Key: 187696383
• Report Number: 1119421-2020-00659
• 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: 05/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: ACU0T0
• Device Lot Number: 12678081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2020
• Initial Date Manufacturer Received: 03/17/2020
• Initial Date FDA Received: 04/09/2020
• Supplement Dates Manufacturer Received: 04/19/2020
• Supplement Dates FDA Received: 05/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED DUOVISC VISCOELASTIC