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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 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).
 
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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 Key5792014
MDR Text Key50210274
Report Number3002037047-2016-00118
Device Sequence Number1
Product Code LZP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P990023
Number of Events Reported1
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 Date07/31/2017
Device Catalogue Number8065183810
Device Lot Number15H31J
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/27/2016
Initial Date FDA Received07/13/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received10/06/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/31/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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