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 Positioning Problem (3009)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

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.(b)(4).

Event Description

A facility representative reported that during an intraocular lens (iol) procedure, the plunger/injector went over the iol.The iol was replaced and the procedure was completed without patient harm.

Manufacturer Narrative

The device with the lens was returned.The plunger lock and lens stop were removed.The plunger was oriented correctly.Viscoelastic was observed in the device.The plunger was located at mid-nozzle upon return.The trailing haptic was folded onto the optic.The optic was torn into two sections (located at mid-nozzle and in the tip).The front torn optic section was rotated.The attached leading haptic was broken at the gusset area.The distal haptic tip was located at mid-nozzle in front of the torn trailing optic section.The nozzle was removed and cleaned for further evaluation.The lens was removed from the nozzle during cleaning.Top coat dye stain testing was conducted with acceptable results.Product history records were reviewed.And the documentation indicated, the product met release criteria.Viscoelastic was not provided.It is unknown, if the qualified product was used.The root cause cannot be determined, for the complaint of plunger override.A plunger override cannot be confirmed.The lens was torn into two portions inside the device.The plunger was engaging the optic at mid-nozzle upon return.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: 11375920
• MDR Text Key: 234905391
• Report Number: 1119421-2021-00420
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 04/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/24/2023
• Device Model Number: ACU0T0
• Device Lot Number: 15092194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2021
• Date Manufacturer Received: 03/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1