MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE SINGLE PIECE ULTRAFLOW SERIES; CATHETER, IRRIGATION

Catalog Number 8065817601

Device Problem Leak/Splash (1354)

Patient Problem Capsular Bag Tear (2639)

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 customer reported that during cataract surgery, two patient's experienced posterior capsule ruptures.The surgeon indicated the ia handpiece was leaking.This report is for one patient.

Manufacturer Narrative

The customer did not return a sample for an evaluation.A photo was provided.A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.A complaint history examination indicates there were no additional complaints associated with the lot for the reported issue.The handpiece was manufactured in march 2005.The photo provided shows the posterior end of the handpiece with the identification for a curved.3mm reusable single piece handpiece.No conclusions can be made about the complaint issue for leakage based on the photo.Because a sample was not returned and the lot information indicates the product was released to the product¿s acceptance criteria, the root cause for the customer complaint issue cannot be determined.The most likely causes for the leakage is from poor fit with the tubing or from excessive tip wear or damage of the approximately 13 year handpiece.All reusable handpieces are 100% visually inspected and functionally tested during the manufacturing process.The manufacturer internal reference number is: (b)(4).

• Brand Name: SINGLE PIECE ULTRAFLOW SERIES
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• MDR Report Key: 8157843
• MDR Text Key: 130165724
• Report Number: 2523835-2018-00510
• Device Sequence Number: 1
• Product Code: GBX
• Combination Product (y/n): N
• PMA/PMN Number: K910245
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065817601
• Device Lot Number: 636600M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other