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U.S. Department of Health and Human Services

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

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JOHNSON & JOHNSON SURGICAL VISION, INC. PLATINUM 1 SERIES SURGICAL ADJUNCTS Back to Search Results
Model Number 1MTEC30
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Patient Involvement (2645)
Event Date 11/11/2020
Event Type  malfunction  
Manufacturer Narrative
If implanted; give date: not applicable, as the cartridge is not an implantable device. If explanted; give date: not applicable, as the cartridge is not an implantable device; therefore, not explanted. Phone: (b)(6). All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
 
Event Description
It has been reported issues with 2 units of 1mtec30. When operating room (or) staff opened 1mtec30 cartridge case, they noticed emeraldc30 cartridge inside. Noticed when removing from packaging. No patient involvement reported. No further information has been provided to johnson & johnson vision. This is report two of two.
 
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Brand NamePLATINUM 1 SERIES
Type of DeviceSURGICAL ADJUNCTS
Manufacturer (Section D)
JOHNSON & JOHNSON SURGICAL VISION, INC.
1700 e st andrew place
santa ana CA 92705
Manufacturer (Section G)
JOHNSON & JOHNSON SURGICAL VISION, INC.
road 402 north, km 4.2
anasco industrial park
anasco PR 00610
Manufacturer Contact
somyata nagpal
1700 east st. andrew place
santa ana, CA 92705
7142478200
MDR Report Key10986699
MDR Text Key220948302
Report Number2648035-2020-00921
Device Sequence Number1
Product Code KYB
Combination Product (y/n)Y
PMA/PMN Number
K081545
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/01/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/12/2020
Device Model Number1MTEC30
Device Catalogue Number1MTEC30
Device Lot NumberCE10130
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/08/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/03/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/12/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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