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

Catalog Number ASKU

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

Patient Problem Inflammation (1932)

Event Date 07/16/2018

Event Type  Injury  

Manufacturer Narrative

No sample has been received by manufacturing for evaluation.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.The manufacturer internal reference number is: (b)(4).

Event Description

A nurse reported that a viscoelastic product exhibited a pearl in the solution while being injected into the eye during cataract surgery.The patient presented one-day postoperatively with toxic anterior segment syndrome (tass) 2+ and was treated with steroids.The patient condition is reported as improving with treatment.Additional information has been requested.

Manufacturer Narrative

No similar complaints have been received so far for this lot.All batches are released according to the required specifications and all initial testing results are within specifications.Investigation of our batch records filling, assembly and blistering showed no remarks related to the reported 'pearl'.A 100% visual inspection process of all filled syringes is performed to remove syringes with large bubbles.No in process control remarks were reported related to this complaint during assembling.At each start up, every 30 minutes and at the end of the working order, a visual inspection is performed on 24 consecutive syringes.No in process control remarks were reported related to this complaint during blistering.At each start up, every 30 minutes and at the end of the working order, a visual inspection is performed on 12 blisters.A small amount of silicone is present.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.Information of batch records compounding and filling showed that there were no related remarks on the production and sterilization process, all analytical results and ipc controls are within specifications.Sterility tests and rabbit tests passed.All results of chemical and microbiological tests were within specification.To date no complaint sample has been returned for evaluation.However, our lab has tested the retain sample of this batch and the results conformed to the specifications for the tested parameters (ph, osmo, lal).As no sample was returned and no manufacturing related issues were identified, a conclusive root cause could not be determined for the two reported deviations.All batches are released according to the required specifications.Possible root causes for the reported 'pearl' may be that the customer observed a silicone droplet or an air bubble.- air bubble: a limited amount of air can be present in the syringe or inherent to the filling and stoppering process of the syringes, however a 100% visual inspection process of all filled syringes is performed to avoid syringes with visible large air bubbles.- silicone droplet: most probably the pearl observed is medical grade silicone that is present on the coated syringe wall to enable glide ability of the stopper.This silicone may accumulate during advancement of the plunger and form small silicone droplets.As a result of complaint trend investigation, it was identified that there is some within specification variability in the siliconizing process with our suppliers.If some more silicone is present, but still within specifications, more oily droplets may be formed during the progressing of the stopper.The silicone oil used is manufactured and tested in compliance with good manufacturing practices at an iso certified facility.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 disposition of the product remains unchanged.As no product is returned and/or insufficient product data is available, the complaint could not be verified and further trending is performed.The manufacturer internal reference number is: (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
• MDR Report Key: 7743895
• MDR Text Key: 115849021
• Report Number: 3002037047-2018-00015
• Device Sequence Number: 1
• Product Code: LZP
• Combination Product (y/n): N
• PMA/PMN Number: P840064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: ASKU
• Device Lot Number: 18D03BC
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other