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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 Contamination (1120)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/01/2019
Event Type  malfunction  
Manufacturer Narrative
Expiration date: unknown, as the lot number was not provided. Lot number: unknown, information not provided. Udi number: a partial udi number is known, as the lot number was not provided. 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. Device manufacture date: unknown as lot number was not provided. Attempts have been made to obtain missing information; however, to date, no response has been received. All pertinent information available to johnson and johnson surgical vision has been submitted.
 
Event Description
It was reported that 9 of the 1mtec30 cartridges had what looked like a white syrup substance infiltrate into the eye as the zcb00 model lens was being implanted. There were 9 cartridges that were reported. Reportedly all 9 patients were not harmed but extensive time was taken to vacuum the substance out of the eye using irrigation and aspiration on the phaco machine. Patient was doing fine. This report is to capture eighth out of 9 cartridges. There are 8 other reports being submitted for this issue. No further information provided.
 
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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 Key8583974
MDR Text Key144266225
Report Number2648035-2019-00546
Device Sequence Number1
Product Code KYB
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K081545
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 01/01/2005,11/11/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/06/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/24/2020
Device Model Number1MTEC30
Device Catalogue Number1MTEC30
Device Lot NumberCE00879
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Report Sent to FDA01/01/2005
Event Location No Information
Date Report to Manufacturer01/10/2005
Date Manufacturer Received10/25/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/24/2019
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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