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

Catalog Number 8065183810

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/08/2016

Event Type  malfunction  

Manufacturer Narrative

No sample or confirmed lot number information 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.(b)(4).

Event Description

A customer reported that the luer-lok adapter and cannula detached from a viscoelastic syringe while in contact with the patient during surgery.An alternate device was obtained in order to continue and complete the procedure.There was no impact to the patient.

Manufacturer Narrative

Additional information is provided in device available for evaluation?, device manufacture date, evaluation codes and additional mfr narrative.No actual sample was received by manufacturing for evaluation.Review of a photo of the complaint device revealed that the luer-lock adapter was detached.No similar complaints are received for this lot.No remarks related to this complaint were reported in the batch record visual inspection.All syringes are visually inspected and items with incompletely assembled luer lock adapters are removed.No loose luer lock adaptors were found for this batch.As no actual sample was returned and no manufacturing related issues were identified, a conclusive root cause could not be determined.As a potential root cause, customer handling could not be eliminated.It is very important that the surgeon properly screws the cannula onto the syringe and that the connection between both devices is checked before using them.Based on the complaint information and the investigation results, we can conclude that the disposition of the product remains unchanged.The complaint could not be verified therefore, no further action is initiated.(b)(4).

• Brand Name: CELLUGEL 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: 5792014
• MDR Text Key: 50210274
• Report Number: 3002037047-2016-00118
• Device Sequence Number: 1
• Product Code: LZP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/06/2016

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: 07/31/2017
• Device Catalogue Number: 8065183810
• Device Lot Number: 15H31J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/27/2016
• Initial Date FDA Received: 07/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2015
• 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