MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CENTURION VISION SYSTEM, ACCESSORY, ACTIVE SENTRY HANDPIECE; UNIT, PHACOFRAGMENTATION

Catalog Number 8065752914

Device Problem Energy Output Problem (1431)

Patient Problems Vitreous Loss (2142); Capsular Bag Tear (2639); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/28/2021

Event Type  Injury  

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.The manufacturer internal reference number is: (b)(4).

Event Description

A surgeon reported that during a cataract extraction with intraocular lens (iol) implant procedure the phacoemulsification (phaco) tip was blocked and the phaco handpiece ultrasonic power was less than normal.The tip was immersed into a cup of solution and applying 100% ultrasonic power attempted to clear the tip.Phaco power modulation continued even with the numbers showing as rising on the system.The tip and handpiece was exchanged but the blockage continued.The patient exhibited progressive zonular dehiscence.Multiple attempts to emulsify the nucleus failed.The surgeon switched to extracapsular cataract extraction procedure.The wound was enlarged and the capsulorhexis was performed.The mostly intact nucleus was removed with a loop instrument.This resulted in vitreous prolapse and an anterior vitrectomy was required.The capsular bag was removed and anterior iol was inserted.The patient was prescribed antibiotic and steroid drops.

Manufacturer Narrative

Additional information has been provided.The phaco handpiece was not returned for evaluation.The phaco handpiece manufacturing device history record (dhr) was reviewed.Based on qa assessment, the product met specifications at the time of release.With no additional, related information provided and no sample received for evaluation at this time, the customer reported event could not be confirmed.The root cause cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).

• Brand Name: CENTURION VISION SYSTEM, ACCESSORY, ACTIVE SENTRY HANDPIECE
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 11893325
• MDR Text Key: 252906629
• Report Number: 2028159-2021-00542
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 00380657529148
• UDI-Public: 00380657529148
• Combination Product (y/n): N
• PMA/PMN Number: K161794
• 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: 08/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065752914
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/03/2021
• Initial Date FDA Received: 05/27/2021
• Supplement Dates Manufacturer Received: 08/05/2021
• Supplement Dates FDA Received: 08/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CENTURION SURGICAL PROCEDURE PAK.; CENTURION VISION SYSTEM WITH ACTIVE SENTRY.; CENTURION SURGICAL PROCEDURE PAK; CENTURION VISION SYSTEM WITH ACTIVE SENTRY
• Patient Outcome(s): Required Intervention