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

Model Number ACU0T0

Device Problems Unintended Ejection (1234); Inaccurate Delivery (2339)

Patient Problem Capsular Bag Tear (2639)

Event Date 05/04/2021

Event Type  Injury  

Manufacturer Narrative

Product evaluation: complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).

Event Description

A healthcare professional reported that during an intraocular lens (iol) implantation procedure, while inserting the iol, the posterior capsular bag ruptured.It was noted that the eye gave a "horse kick" during implantation.An alternate iol was implanted and "disinsertion" of the capsular bag occurred.

Manufacturer Narrative

The device was returned loose in the carton for the reported product.The mylar label had been removed.The label was indicated to have been removed by the surgeon to evaluate the plunger.Without the identifying mylar label, it cannot be confirmed that the returned device is the reported device.The plunger lock and lens stop had been removed.The plunger was oriented correctly.Viscoelastic was observed in the device.The plunger was retracted.The device, plunger, barrel and nozzle assemblies were evaluated.No device damage was observed.The nozzle was removed and cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results.During evaluation, it was noted that the returned, unlabeled complaint sample had an company preload v3.5 extended tip ¿d¿ nozzle where the complaint sample should have been equipped with an company preload ¿c¿ nozzle.A video was provided of the lens delivery.The device preparation and initial advancement were not shown.A clinical assessment was provided by the subject matter expert (sme) for delivery systems.Product history records were reviewed and documentation indicated the product met release criteria.Viscoelastic was not provided.It is unknown if a qualified product was used.The root cause for the pc-tear could not be determined.No device damage was observed.Top coat dye stain testing was conducted with acceptable results.The sme assessment was that a 28.0d company lens - if delivered through the ¿d¿ size nozzle - would not likely suddenly "jump" as a it was observed on the provided video.The complaint sample was only one diopter higher than the maximum diopter qualified for the ¿d¿ size company preload nozzle, which is 27.0d.The diopter cutoff of 27.0 as specified in the instructions for use (ifu), was related to the increased likelihood for lens damage as the diopter increases.The 27.0 diopter cut-off was not related to delivery control or to preventing the type of ¿jump¿ that was observed on the video.The sme assessment was that the incorrect nozzle type did not play a role in cause of the reported capsular bag tear.Ophthalmic viscosurgical device (ovd) type, ovd amount, and other use variables were requested, but remain unknown.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: 11809898
• MDR Text Key: 250214695
• Report Number: 1119421-2021-01006
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 00380652395410
• UDI-Public: 00380652395410
• 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: 10/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/11/2024
• Device Model Number: ACU0T0
• Device Lot Number: 15126401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2021
• Date Manufacturer Received: 09/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HYBRID TIP OF CENTURION; SURGICAL PRODUCT, UNSPECIFIED
• Patient Outcome(s): Other; Required Intervention