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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 05/31/2019
Event Type  malfunction  
Manufacturer Narrative
Age/date of birth: unknown, information not provided. Gender/sex: unknown, information not provided. Implant date: not applicable as this is not an implantable device. Explant 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 lot history record and complaint trending for this device will be performed. Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed. All pertinent information available to johnson and johnson surgical vision has been submitted.
 
Event Description
It was reported that when inserting the intraocular lens (iol) into the eye, the surgeon noticed a foreign body was released into the eye along with the lens. The materiel was described as looking like ''a piece of the cartridge'' however the cartridge was intact. Additional information revealed there was no patient injury and the patient was doing fine post-operatively. No additional information was 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 Key8745613
MDR Text Key149553256
Report Number2648035-2019-00670
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
Report Date 01/01/2005,11/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2019
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 NumberCE00876
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/02/2019
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? Device Not Returned to Manufacturer
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

Patient Treatment Data
Date Received: 06/28/2019 Patient Sequence Number: 1
Treatment
ZXR00 INTRAOCULAR LENS SERIAL #: UNKNOWN
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