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

Catalog Number ASKU

Device Problems Particulates (1451); Sediment, Precipitate Or Deposit In Device Or Device Ingredient (3021)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/11/2015

Event Type  malfunction  

Event Description

A doctor reported that cloudy particulate matter was noted inside of the viscoelastic solution during surgery which had to be displaced from the anterior chamber in order to continue with the cataract procedure.There was no impact to the patient.Additional information has been requested.

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.The manufacturer internal reference number is: 2015-11997.

Manufacturer Narrative

No similar complaints have been received so far for this lot.All batches are released according to the required specifications.All testing results were within specifications for this batch.As a complaint sample, an almost empty viscoelastic syringe was received.Since the volume of solution inside of the returned syringe was insufficient, no testing could be performed regarding this issue.A 100% visual inspection process of all filled syringes is performed to remove syringes with large silicone droplets and particulate matter.We can inform you that 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 in order to permit proper function of the syringe.The low levels of silicone oil do not elicit local ocular or systemic toxicity.(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-28 70; BE B-2870
• Manufacturer Contact: eddie darton, md, jd ; mail stop ab2-6; mail stop r3-48; fort worth, TX 76134 ; 8175686660
• MDR Report Key: 4684454
• MDR Text Key: 5639175
• Report Number: 3002037047-2015-00510
• 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: 06/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/13/2017
• Device Catalogue Number: ASKU
• Device Lot Number: 14K03F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2014
• 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
• Patient Age: 68 YR
• Patient Weight: 77