MAUDE Adverse Event Report: ALCON RESEARCH, LLC - ALCON PRECISION DEVICE DISPOSABLE POLYMER IRRIGATION AND SILICONE IRRIGATION AND ASPIRATION TIPS; DEVICE, IRRIGATION, OCULAR SURGERY

Catalog Number 8065751511

Device Problems Dull, Blunt (2407); Pressure Problem (3012)

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

Event Date 02/25/2022

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 physician reported that while using an irrigation/aspiration tip a patient experienced posterior capsule rupture and there was burr on the tip during a cataract surgery.The surgery was completed after replacing the product with another one.Additional information has been requested none received.

Manufacturer Narrative

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

Event Description

Additional information received clarifying capsule rupture resulted in slow rise of visual acuity and increase in intraocular pressure.The procedure type was altered from iol intracapsular fixation to iol extracapsular fixation.

Manufacturer Narrative

Two opened irrigation/aspiration (ia) tips were received for the report of burr on the tip.The returned samples were visually inspected and both samples were found to be conforming.A video of the surgery was provided and has been reviewed by the manufacturing site.No defects related to the ia tip seen in the video were able to be observed.A review of the device history record traceable to the reported lot number indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.The returned samples were found to be conforming for all visual inspections associated with the reported event, therefore a burr as described in the complaint was not confirmed and a root cause cannot be determined for the complaint as described by the customer.No action was taken as the illuminator was manufactured to specification.All i/a tips are 100% visually inspected prior to being released from the manufacturing facility.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No adverse trends have been observed associated with the reported product and event.No further actions are required.The manufacturer internal reference number is: (b)(4).

• Brand Name: DISPOSABLE POLYMER IRRIGATION AND SILICONE IRRIGATION AND ASPIRATION TIPS
• Type of Device: DEVICE, IRRIGATION, OCULAR SURGERY
• Manufacturer (Section D): ALCON RESEARCH, LLC - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• Manufacturer (Section G): ALCON RESEARCH, LLC - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 13905088
• MDR Text Key: 287924605
• Report Number: 2523835-2022-00121
• Device Sequence Number: 1
• Product Code: KYG
• UDI-Device Identifier: 00380657515110
• UDI-Public: 00380657515110
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: 8065751511
• Device Lot Number: 13W8UR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CENTURION VISION SYSTEM WITH ACTIVE SENTRY
• Patient Outcome(s): Other