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 Activation, Positioning or Separation Problem (2906)

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

Event Type  malfunction  

Manufacturer Narrative

A sample device was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.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) procedure, the plunger went over the iol during an intraocular lens (iol) implantation procedure.The procedure was completed with an alternate lens.There was no patient harm reported.

Manufacturer Narrative

The device with the lens was returned.The plunger lock and lens stop have been removed.The plunger was oriented correctly.Viscoelastic was observed in the device.The plunger was advanced to mid-nozzle and has overrode the lens.The lens was located between the loading area and the nozzle area.The trailing haptic was folded onto the optic along the left side of the plunger.The leading haptic was ahead of the optic and located under the plunger.The nozzle was cleaned for further evaluation.The lens was removed, during cleaning.Top coat dye stain testing was conducted with acceptable results.Product history records were reviewed.And documentation indicated, the product met release criteria.A qualified viscoelastic was indicated.The root cause cannot be determined, for the reported event.A plunger override was observed.The plunger was at mid-nozzle.A qualified viscoelastic was indicated.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: 11375958
• MDR Text Key: 234616784
• Report Number: 1119421-2021-00423
• 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: 04/08/2021

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: 06/26/2023
• Device Model Number: ACU0T0
• Device Lot Number: 15079052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2021
• Initial Date Manufacturer Received: 02/05/2021
• Initial Date FDA Received: 02/24/2021
• Supplement Dates Manufacturer Received: 03/17/2021
• Supplement Dates FDA Received: 04/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PROVISC