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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 11/26/2019
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; therefore, not explanted. Additional concomitant product - healon pro lot#: ue31597. Phone: (b)(6). The cartridge is not returning for evaluation. Therefore, a failure analysis of the complaint device cannot be completed. A review of the device history record, labeling, complaint trending, and risk documentation 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 and johnson surgical vision, inc. Has been submitted.
 
Event Description
It was reported that after a perfect preparation as per directions of use (dfu) of the zct100 lens, the doctor implanted the intraocular lens (iol) and discovered a little blue string. Through irrigation/aspiration (i/a) she was able to remove it. The surgeon kept the healon pro, the cartridge and the alcon tubing set with particle somewhere in it as well. No patient issues are being reported. Through follow-up we learned that the surgeon considers only the lens and the cartridge as suspect. It was confirmed that material is not returning. No additional 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 Key9513629
MDR Text Key179473967
Report Number2648035-2019-01371
Device Sequence Number1
Product Code KYB
Combination Product (y/n)Y
Reporter Country CodeNL
PMA/PMN Number
K081545
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/01/2005,11/05/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/23/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/29/2020
Device Model Number1MTEC30
Device Catalogue Number1MTEC30
Device Lot NumberCE01183
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 Manufactured01/29/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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