MAUDE Adverse Event Report: ALCON - COUVREUR N.V./ALCON - BELGIUM VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE; AID, SURGICAL, VISCOELASTIC

Catalog Number ASKU

Device Problems Particulates (1451); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/28/2015

Event Type  malfunction  

Manufacturer Narrative

A sample has been received by manufacturing that has not yet been evaluated.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.Additional information has been requested.This is the second of two reports from this facility.The manufacturer internal reference number is: (b)(4).

Event Description

A health professional reported that round silicone particles were noted inside of viscoelastic product during surgery.There was no impact to the patient.Additional information has been requested.

Manufacturer Narrative

All batches are released according to the required specifications and all testing results were within specification for this batch.A small amount of silicone was found in the initial samples.Sixteen unopened samples were received by manufacturing.Our lab retested a reference sample of this batch as well as the returned samples and all results conformed to the specifications for the tested parameters: clear and colorless with a small amount of silicone present.We can inform you that a 100% visual inspection process of all filled syringes is performed to remove syringes with large silicone droplets.The silicone oil used is manufactured and tested in compliance with good manufacturing practices at an iso certified facility.Medical grade silicone is used to coat all types of stoppers and syringe barrels to permit proper function of the syringe.The low levels of silicone oil do not elicit local ocular or systemic toxicity.Based on the complaint information and the investigation results, we can conclude that the dispositioned product met specifications and remains unchanged, no problem was found.Further trending is performed.(b)(4).

• Brand Name: VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE
• Type of Device: AID, SURGICAL, VISCOELASTIC
• Manufacturer (Section D): ALCON - COUVREUR N.V./ALCON - BELGIUM; rijksweg 14; puurs B-287 0; BE B-2870
• Manufacturer (Section G): ALCON - COUVREUR N.V./ALCON - BELGIUM; rijksweg 14; puurs B-287 0; BE B-2870
• Manufacturer Contact: eddie darton, md, jd ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175686660
• MDR Report Key: 5276114
• MDR Text Key: 33365899
• Report Number: 3002037047-2015-00582
• Device Sequence Number: 1
• Product Code: LZP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Catalogue Number: ASKU
• Device Lot Number: 15F03V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2015
• 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