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

Catalog Number 160901515SGP

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/23/2016

Event Type  malfunction  

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.(b)(4).

Event Description

A nurse manager reported that a viscoelastic cannula exhibited deposits after the product was used during surgery.There was no impact to the patient.Additional information has been requested.Additional information was received clarifying that the kit provided cannula exhibited white specks that did not detach or deposit into the patient's eye.The patient is well with nothing unexpected.

Manufacturer Narrative

A complaint history review was performed and no similar complaints have been received for this lot.Investigation of our batch record showed no remarks were reported during batch record blistering.There were no reported in process control remarks related to this complaint.The blisters are 100% inspected after blistering for foreign material inside the blister.One completely used syringe was received as complaint sample.The cannula is assembled on the syringe, but the locking collar is not available.Investigation showed that no deposits are present on the cannula tip.A deformation is present on the sleeve at the height of the screw thread as well as on the cannula hub which appear scorched.It is observed that this damage runs through both components.We are, however, not sure whether this deformation is related to the reported complaint.As this concerns an isolated complaint for this lot with no white deposits observed to the returned cannula and no manufacturing related issues identified, we cannot confirm the complaint as reported.A conclusive root cause for the deformation, which is present to the screw thread of the sleeve and the cannula hub, cannot be determined.The cannula is supplied in a closed cartridge and is only assembled by the customer.Since the scorched appearance damage on the returned sample is observed on both components, we can exclude that this damage was caused during one of the production processes.Since the sample was returned by courier to our manufacturing plant in a damaged bag, outer as well as the inner bags, potentially this damage could be related to an external factor during transportation to our plant; customer handling could also not be excluded for this damage since the damage occurred after assembly of the cannula.To further determine if the reported complaint of white deposits might be associated with a component related issue, an additional investigation was performed by the cannula component manufacturer site.Per the cannula manufacturing evaluation, one opened cannula on a syringe was received for the report of deposits on cannula tip.The cannula was visually inspected per facility procedure and was found to be conforming with no deposits on the cannula.During evaluation, it was noted that there was procedural residue on the tip of the cannula.The evaluation does not confirm the deposits on the cannula tip seen by the customer.The cannula was visually conforming.Based on the complaint information and the investigation results, we can conclude that the disposition of the product remains unchanged.The customer's complaint could not be verified.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
• 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: 5514240
• MDR Text Key: 41144706
• Report Number: 3002037047-2016-00050
• Device Sequence Number: 1
• Product Code: LZP
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: P840064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: 160901515SGP
• Device Lot Number: 15I14Q
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2016
• Initial Date FDA Received: 03/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2015
• 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
• Patient Age: 72 YR