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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 08/05/2019
Event Type  malfunction  
Manufacturer Narrative
Age/date of birth: unknown/ not provided. Sex/gender: unknown/ 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. Concomitant medical products: healon endocoat, lot number 027850. Concomitant medical products: healon pro, lot number ue31334. The device is not returning for evaluation as lens remains implanted and cartridge was discarded; therefore, a failure analysis of the complaint device cannot be completed. A review of the device/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 & johnson surgical vision, inc. Has been submitted.
 
Event Description
During a site visit, an observation was made there was some amount of ''viscous material'' coming out of a 1mtec30 cartridge during deployment of a zcb00 intraocular lens (iol). The viscous material was like a residual precipitate, small amount. There were no patient post-op injuries reported and the lens remains implanted. Unfortunately, no product will be returned. The reporter believes that the ¿white syrup¿ material might have come from the cartridge. Through follow-up it was learned that the debris/foreign matter was inside the eye after deployment, and the surgeon removed the debris using forceps. No other 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 Key8951377
MDR Text Key156495241
Report Number2648035-2019-00939
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 01/01/2005,11/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/02/2019
Device Model Number1MTEC30
Device Catalogue Number1MTEC30
Device Lot NumberCD11842
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
Date Device Manufactured11/02/2018
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: 08/30/2019 Patient Sequence Number: 1
Treatment
ZCB00, SERIAL NUMBER (B)(4)
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