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 Component (1104)

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

Event Type  malfunction  

Manufacturer Narrative

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

The director of surgical services at a facility reported that as the surgeon went to inject the viscoelastic, the entire hub that the needle tip is inserted in to, came off the syringe itself.There was no patient harm.Samples are available.Additional information has been requested.

Manufacturer Narrative

The investigation showed that no remarks related to this complaint were reported in the batch record filling and visual inspection : all syringes are visually inspected, items with incompletely assembled luer lock adapters are removed.No loose luer lock adaptors were found for this batch.To date no sample has been received; no further investigation can be done.We can however inform you that after previous similar complaints, investigation of the complaint samples has been performed by the manufacturer of the syringes.Results of these investigation showed that there were no deviations related to the individual components.Dimensions and functionality were tested and were conform for the glass barrel as well as the plastic (b)(4).After reassembly of the (b)(4) , it was not possible to simulate detachment on the complaint samples if assembled according to the directions for use (dfu).However, when these instructions for use were not followed or if other non-alcon components were used, a malfunctioning of the device could be simulated.The root cause was unable to be determined due to no sample being returned.A probable root cause may be related to customer manipulation.(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: 4923005
• MDR Text Key: 22474296
• Report Number: 3002037047-2015-00544
• 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: company representative,health
• Reporter Occupation: Other
• Report Date: 09/21/2015

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: 01/31/2017
• Device Catalogue Number: 8065183810
• Device Lot Number: 15C12E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other