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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON AND JOHNSON SURGICAL VISION, INC. PLATINUM 1 SERIES SURGICAL ADJUNCTS

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JOHNSON AND JOHNSON SURGICAL VISION, INC. PLATINUM 1 SERIES SURGICAL ADJUNCTS Back to Search Results
Model Number 1MTEC30
Device Problem Device Contamination with Chemical or Other Material
Event Date 04/27/2018
Event Type  Malfunction  
Manufacturer Narrative

If implanted, give date: not applicable as this is not an implantable device if explanted, give date: not applicable as this is not an implantable device concomitant medical products: (b)(4) viscoelastic, lot 027038; phaco tip (b)(4), lot f92186. (b)(6). All pertinent information available to johnson and johnson surgical vision, inc. Has been submitted.

 
Event Description

It was reported that two foreign filaments were found in the anterior chamber of the patient's eye right after the intraocular lens (iol) implantation and the irrigation/aspiration (i/a) procedure. There was a delay of 10 minutes in the procedure but no secondary surgical or medical intervention was required. The account believes that the filaments are coming from either the cartridge, the viscoelastic or the phaco tip; therefore 2 mdrs will be filed. This is to record the cartridge. A separate report will be submitted for the viscoelastic endocoat.

 
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Brand NamePLATINUM 1 SERIES
Type of DeviceSURGICAL ADJUNCTS
Manufacturer (Section D)
JOHNSON AND JOHNSON SURGICAL VISION, INC.
santa ana CA
Manufacturer (Section G)
JOHNSON AND JOHNSON SURGICAL VISION, INC.
road 402 north, km 4.2
anasco industrial park, pob 14
anasco PR 00610
Manufacturer Contact
pam mcclain
1700 east st. andrew place
santa ana , CA 92705
7142478243
MDR Report Key7546803
Report Number2648035-2018-00783
Device Sequence Number1
Product CodeKYB
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/01/2005,04/26/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/25/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device EXPIRATION Date01/25/2019
Device MODEL Number1MTEC30
Device Catalogue Number1MTEC30
Device LOT NumberCD01199
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/27/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Event Location No Information
Date Report TO Manufacturer01/10/2005
Date Manufacturer Received04/08/2019
Is this a Reprocessed and Reused Single-Use Device? No

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