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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 Problems Crack (1135); Device Contaminated During Manufacture or Shipping (2969)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/02/2020
Event Type  malfunction  
Manufacturer Narrative
Lot number: unknown, information not provided. Unique device identifier (udi #): unknown, as lot number was not provided. Expiration date: unknown, as 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 & johnson surgical vision, inc. Has been submitted.
 
Event Description
It was reported that when placing the lens it was noticed there was an extra piece of something in the eye. Upon closer inspection, it was a piece of plastic that had broken away from the underside of the tip on the cartridge. Surgeon did manage to extract the piece of plastic and leave the iol in place. There was no use error. 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 Key10946709
MDR Text Key219567514
Report Number2648035-2020-00909
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 distributor,health profession
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/31/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1MTEC30
Device Catalogue Number1MTEC30
Device Lot NumberUNKNOWN
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 Received01/08/2021
Was Device Evaluated by Manufacturer? Yes
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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