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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 Material Fragmentation; Device Contamination with Chemical or Other Material
Event Date 05/17/2018
Event Type  Malfunction  
Manufacturer Narrative

This is not an implantable device. Product lot number was not provided. Attempts have been made to obtain missing information; however, to date, the requested information has not been provided. All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.

 
Event Description

The surgery center reported that during the implantation of an intraocular lens (iol), a piece of the platinum cartridge, model 1mtec30 chipped off and got into the patient's operative eye. The piece of cartridge was removed from the eye, but the lens remains implanted. Reportedly, the patient is doing fine post-operation and there was no injury reported. No further information was provided.

 
Manufacturer Narrative

Device available for evaluation; returned to manufacturer on: 07/20/2018. Device evaluation: the product was returned to the manufacturing site for evaluation. Visual inspection using microscope magnification was performed and showed residue of lubricant material on the cartridge. The cartridge tip section was observed deformed and damaged. The condition observed is consistent with a cartridge tip that has been damaged by the contact of the metal rod tip from the hand piece tool during surgical process. The complaint issue reported as cartridge damaged was verified. Manufacturing records review: manufacturing record review could not be performed since lot number is unknown. Labeling review: the directions for use (dfu) was reviewed. The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device. As a result of the investigation, there is no indication of a product quality deficiency and the reported issue could not be verified. All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.

 
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Brand NamePLATINUM 1 SERIES
Type of DeviceSURGICAL ADJUNCTS
Manufacturer (Section D)
JOHNSON & JOHNSON SURGICAL VISION, INC.
santa ana CA 92705
Manufacturer (Section G)
JOHNSON & JOHNSON SURGICAL VISION, INC.
road 402 north, km 4.2
anasco industrial park, pob 14
anasco PR 00610
Manufacturer Contact
pamela mcclain
1700 east st. andrew place
santa ana , CA 92705
7142478243
MDR Report Key7612863
Report Number2648035-2018-00886
Device Sequence Number1
Product CodeKYB
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/01/2005,09/05/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/19/2018
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? Device Returned To Manufacturer
Date Returned to Manufacturer07/20/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Event Location No Information
Date Report TO Manufacturer01/10/2005
Date Manufacturer Received08/13/2018
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 06/19/2018 Patient Sequence Number: 1
Treatment
MONOFOCAL IOLS, TECNIS 1-PIECE, SN UNKNOWN
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