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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 Type  malfunction  
Manufacturer Narrative
Age/date of birth: unknown, information not provided. Gender/sex: unknown, information not provided. Date of event: unknown, information not provided. Expiration date: unknown, as the lot number was not provided. Lot number: unknown, information not provided. Udi number: a partial udi number is known, as the lot number was not provided. If implanted, if explanted, give date: not applicable as this is not an implantable device. Device manufacture date: unknown as lot number was not provided. Device evaluation: sample is not available for investigation complaint could not be verified. Manufacturing records review: the manufacturing record evaluation could not be performed since the lot number is unknown. Attempts have been made to obtain missing information; however, to date, no response has been received. All pertinent information available to johnson and johnson surgical vision has been submitted.
 
Event Description
It was reported that doctor had couple of 1mtec30 cartridges more over the past months which had white syrup substance infiltrate into the eye as the zcboo lens was being implanted. Luckily the doctor was able to aspirate the substance out of the eye. In all the cases zcb00 lens were used and healon duet was used as concomitant product. Reportedly the products were stored in the site at a temperature between 58-degree fahrenheit and 68 degree fahrenheit. Per customer the material looked fibrous and was coming out of leading edge and not the trailing edge. The exact quantity is unknown. This event will capture information for 1 cartridge. Another report is being submitted for other cartridge. 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 Key8801193
MDR Text Key151425540
Report Number2648035-2019-00733
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
Report Date 01/01/2005,11/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/18/2019
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? 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
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/18/2019 Patient Sequence Number: 1
Treatment
ZCB00 LENS SN: UNKNOWN, HEALON DUET LOT# UNKNOWN
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