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U.S. Department of Health and Human Services

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

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ALCON - COUVREUR N.V./ALCON - BELGIUM CELLUGEL OPHTHALMIC VISCOSURGICAL DEVICE AID, SURGICAL, VISCOELASTIC Back to Search Results
Catalog Number 8065183810
Device Problems Hub (469); 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).

 
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Brand NameCELLUGEL OPHTHALMIC VISCOSURGICAL DEVICE
Type of DeviceAID, 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 Key4923005
MDR Text Key22474296
Report Number3002037047-2015-00544
Device Sequence Number1
Product Code LZP
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP990023
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/21/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/17/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/31/2017
Device Catalogue Number8065183810
Device LOT Number15C12E
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/08/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/12/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

Patient TREATMENT DATA
Date Received: 07/17/2015 Patient Sequence Number: 1
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