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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 Problem Device Contamination with Chemical or Other Material
Event Date 04/23/2018
Event Type  Malfunction  
Manufacturer Narrative

Lot#: unknown/not provided. Expiration date: unknown as product lot number was not provided. Udi #: a complete udi # is unknown as product lot number was not provided. If implanted; give date: n/a (not applicable). The cartridge is not an implantable device. If explanted; give date: n/a (not applicable). The cartridge is not an implantable device; therefore, not explanted. (b)(6). Device manufacture date: unknown as product lot number was not provided. All pertinent information available to johnson and johnson surgical vision, inc. Has been submitted.

 
Event Description

The customer reported that a small piece of hard plastic has come through the cartridge with the lens. The lens was implanted without patient injury. No additional information was provided to johnson and johnson surgical vision, inc.

 
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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
pamela mcclain
1700 east st. andrew place
santa ana , CA 92705
7142478243
MDR Report Key7552945
Report Number2648035-2018-00792
Device Sequence Number1
Product CodeKYB
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,U
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/01/2005,08/15/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/30/2018
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 Manufacturer06/22/2018
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 Received07/17/2018
Is this a Reprocessed and Reused Single-Use Device? No

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