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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 Contamination with Chemical or Other Material
Event Date 07/17/2018
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.   it was indicated that the device is not returning for evaluation; therefore a failure analysis of the complaint device cannot be completed. A review of the device/lot history record, labeling, complaint trending, and risk documentation for this device can not be performed as a lot number was not provided. If there is any further relevant information a supplemental medwatch will be filed. All pertinent information available to johnson and johnson vision has been submitted.

 
Event Description

It was reported that customer opened the package of the cartridge and noticed a human hair inside the sterilized package. Reportedly there was no patient contact. No further information provided.

 
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Brand NamePLATINUM 1 SERIES
Type of DeviceSURGICAL ADJUNCTS
Manufacturer (Section D)
JOHNSON & JOHNSON SURGICAL VISION, INC.
santa ana CA
Manufacturer (Section G)
JOHNSON & JOHNSON SURGICAL VISION, INC
road 402 north, km 4.2
anasco industrial park
anasco PR 00610
Manufacturer Contact
pam mcclain
1700 east st. andrew place
santa ana , CA 92705
7142478243
MDR Report Key7792136
Report Number2648035-2018-01108
Device Sequence Number1
Product CodeKYB
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation
Type of Report Initial
Report Date 01/01/2005,08/16/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/16/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number1MTEC30
Device Catalogue Number1MTEC30
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
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 Received07/18/2018
Is this a Reprocessed and Reused Single-Use Device? No

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