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

Model Number	ACU0T0
Medical Device Problem Codes	Unintended Ejection (1234); Inaccurate Delivery (2339)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	05/04/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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and lens stop had been removed.The plunger was oriented correctly.Viscoelastic was observed in the device.The plunger was retracted.The device, plunger, barrel and nozzle assemblies were evaluated.No device damage was observed.The nozzle was removed and cleaned for further evaluation.Top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
• Common Device Name: LENS, GUIDE, INTRAOCULAR
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 11809898
• Report Number: 1119421-2021-01006
• Device Sequence Number: 3515172
• Product Code: KYB
• UDI-Device Identifier: 00380652395410
• UDI-Public: 00380652395410
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2021

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?: No
• Operator of Device: 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
• Initial Date Received by Manufacturer: 05/05/2021
• Supplement Date Received by Manufacturer: 09/07/2021
• Initial Report FDA Received Date: 05/11/2021
• Supplement Report FDA Received Date: 10/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HYBRID TIP OF CENTURION; SURGICAL PRODUCT, UNSPECIFIED
• Outcome Attributed to Adverse Event: Other; Required Intervention