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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON AND JOHNSON SURGICAL VISION, INC. PLATINUM 1 SERIES SURGICAL ADJUNCTS

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JOHNSON AND JOHNSON SURGICAL VISION, INC. PLATINUM 1 SERIES SURGICAL ADJUNCTS Back to Search Results
Model Number 1MTEC30
Device Problems Break; Device Contamination with Chemical or Other Material
Event Date 05/07/2018
Event Type  Malfunction  
Manufacturer Narrative

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. (b)(6). All pertinent information available to johnson and johnson surgical vision, inc. Has been submitted.

 
Event Description

It was reported that during implantation of an intraocular lens (iol), or while pulling the injector out of the patient's eye, a small piece of plastic broke off the cartridge. Reportedly, the plastic piece was removed without injury. No further information was provided.

 
Manufacturer Narrative

Device available for evaluation? yes. Returned to manufacturer on: 06/06/2018. Device returned to manufacturer? yes. Device evaluation: the cartridge was returned at the manufacturing site for evaluation. Visual inspection at 10x microscope magnification showed traces of viscoelastic at the cartridge tip. The cartridge was observed deformed/cracked (split). The visual inspection does not reveal a molding defect. The conditions of the returned sample suggested that the cartridge tip could have been broken with the handpiece push rod. The customer's reported complaint for cartridge broken was verified. Manufacturing records review: the manufacturing records for the cartridge were reviewed. During manufacturing the operators inspect the neck, tube and tip areas for cracks. No cracking or stress marks are allowed. They also check the tip for any melting, roughness, dent, bent tip or smash condition. The product was manufactured and released according to specification. A search revealed that no additional investigation requests for this order number have been received. Labeling review: the directions for use (dfu) were reviewed. The directions for use (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. All pertinent information available to johnson and johnson surgical vision, inc. Has been submitted.

 
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Brand NamePLATINUM 1 SERIES
Type of DeviceSURGICAL ADJUNCTS
Manufacturer (Section D)
JOHNSON AND JOHNSON SURGICAL VISION, INC.
santa ana CA
Manufacturer (Section G)
JOHNSON AND JOHNSON SURGICAL VISION, INC.
road 402 north, km 4.2
anasco industrial park, pob 14
anasco PR 00610
Manufacturer Contact
pam mcclain
1700 east st. andrew place
santa ana , CA 92705
7142478243
MDR Report Key7568157
Report Number2648035-2018-00830
Device Sequence Number1
Product CodeKYB
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/01/2005,07/19/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/05/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device EXPIRATION Date03/08/2019
Device MODEL Number1MTEC30
Device Catalogue Number1MTEC30
Device LOT NumberCD02750
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/06/2018
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 Received07/05/2018
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 06/05/2018 Patient Sequence Number: 1
Treatment
IOL, MODEL AND SERIAL NUMBER UNKNOWN
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