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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 12/09/2019
Event Type  malfunction  
Manufacturer Narrative
Age/date of birth: unknown, information not provided. Gender/sex: unknown, information not provided. If implanted; give date: n/a (not applicable). The cartridge is not an implantable device. If explanted; give date: n/a (not applicable). The cartridge is not an implantable device; therefore, not explanted. (b)(6). All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
 
Event Description
It was reported that after implanting the intraocular lens (iol), foreign substance was on the iol. Extra time was needed to remove the sticky substance on the iol the substance pattern could be silk-like. Doctor checked iol under microscope and it was clear, thinks problem is not caused by iol. Although the silk-like substance can be removed, the doctor thinks that it is not normal. Additional information states the lens is implanted and there are no injuries. No further information is 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 Key9560877
MDR Text Key179801570
Report Number2648035-2020-00025
Device Sequence Number1
Product Code KYB
Combination Product (y/n)Y
Reporter Country CodeTW
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 01/01/2005,11/04/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/07/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/02/2020
Device Model Number1MTEC30
Device Catalogue Number1MTEC30
Device Lot NumberCE04218
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/14/2020
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 Manufactured05/02/2019
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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