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

Catalog Number 960505CO-001

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/13/2015

Event Type  malfunction  

Event Description

An instrumentist reported that the cannula detached and made contact with the patient's eye during surgery.Patient impact is unknown.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, but none has been received.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

No similar complaints have been received for the identified lot.Investigation showed that no remarks related to this complaint were reported in the batch record and 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 the identified lot batch.As a complaint sample, two viscoelastic syringes with attached manufacturer provided cannulas were received inside of the product carton.One syringe was empty and the other was partially used.Investigation showed that the luer lock adapter became loose from the groove.A retest of the returned syringes was performed after reaffirming the luer lock adapter and cannula and the results were satisfactory.Please note that it is very important to properly screw the cannula onto the syringe by holding both the luer lock adapter and the syringe while twisting.Also, visually inspect that the cannula hub has traveled the full length of the luer lock adapter.Probably these directions for use were not followed correctly by the customer.The most probable root cause is customer manipulation.The manufacturer internal reference number is: (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-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: 4769819
• MDR Text Key: 5790311
• Report Number: 3002037047-2015-00522
• Device Sequence Number: 1
• Product Code: LZP
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: P990023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2016
• Device Catalogue Number: 960505CO-001
• Device Lot Number: 14C18D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2014
• 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