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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 Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Date of event: exact date unknown, not provided. Best estimate (b)(6) 2019. If implanted; if explanted; give date: n/a (not applicable). The cartridge is not an implantable device. All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
 
Event Description
It was reported that the doctor is seeing an increase in plaques coming from the cartridges at time of lens injection. Maybe 50% of recent cases. The doctor shared two (2) specific case images that occurred recently with a flake of material that goes in from the injector with the lens. It was also stated that the debris is easy to take out by irrigation and aspiration (ia). Follow-up noted that they have had this issue before (approx. 2 years ago) and it went away from some time and manifested again around the beginning of summer, but no exact dates or other specific information provided. It was learned that all patients had no adverse events and one of the doctor¿s colleagues did leave it in the eye and the patient was fine. No other information was provided. 2 mdr reports are required, one for each case reported. This mdr is to capture case#1. Another mdr is submitted to capture case #2.
 
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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 Key9188878
MDR Text Key166320895
Report Number2648035-2019-01094
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 health professional,user faci
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/01/2005,11/09/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/14/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/26/2020
Device Model Number1MTEC30
Device Catalogue Number1MTEC30
Device Lot NumberCE06376
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/29/2019
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 Manufactured06/26/2019
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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