MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE SILICONE IRRIGATION AND ASPIRATION TIPS; DEVICE, IRRIGATION, OCULAR SURGERY

Catalog Number 8065740970

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

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 observing "sharp, saw tooth edge and burr" on a new, unused irrigation/aspiration tip through microscopy.

Manufacturer Narrative

No sample has been returned for evaluation; therefore, the condition of the product could not be verified.The customer supplied photos of the reported complaint sample and these were reviewed.A much higher magnification was used to display a jagged surface on the tip.The surface would be considered visually conforming at 20x magnification used per facility inspection procedure.A review of the related device history records (dhr) for the reported lot number has been performed; no anomalies were found.The product was released based on the products acceptance criteria.The lot complaint history was reviewed; this is the first complaint for the reported lot number.Because a sample was not returned and no lot information is available, the root cause for the customer complaint issue cannot be determined.The photography supplied by the customer is at a significantly higher magnification than the product specifications.A cross functional team of manufacturing, quality and engineering reviewed this complaint and determined that the photography did not demonstrate an out of specification condition for the product.An internal investigation has been opened.The manufacturer internal reference number is: (b)(4).

• Brand Name: SILICONE IRRIGATION AND ASPIRATION TIPS
• Type of Device: DEVICE, IRRIGATION, OCULAR SURGERY
• Manufacturer (Section D): ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• Manufacturer (Section G): ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• Manufacturer Contact: eddie darton, md, jd ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175686660
• MDR Report Key: 5079507
• MDR Text Key: 26192665
• Report Number: 2523835-2015-00841
• Device Sequence Number: 1
• Product Code: KYG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Followup
• Report Date: 01/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065740970
• Device Lot Number: 986701M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other