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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 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 will be performed. Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed. Attempts have been made to obtain missing information; however, to date, no response has been received. All pertinent information available johnson & johnson surgical vision, inc. Has been submitted.

 
Event Description

It was reported that surgeon noticed sliver or fragment during the procedure and stated it could be from cartridge as it was too large to come from healon. Surgeon removed the fragment and gave to his staff. A model zxr00 intraocular lens was used during the procedure. 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, pob 14
anasco PR 00610
Manufacturer Contact
pam mcclain
1700 east st. andrew place
santa ana , CA 92705
7142478243
MDR Report Key7563657
Report Number2648035-2018-00825
Device Sequence Number1
Product CodeKYB
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 06/01/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/02/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device EXPIRATION Date08/09/2018
Device MODEL Number1MTEC30
Device Catalogue Number1MTEC30
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/04/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/09/2017
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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