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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 Known Impact Or Consequence To Patient (2692)
Event Date 10/17/2019
Event Type  malfunction  
Manufacturer Narrative
Age/date of birth: unknown, information 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 device z hyalan viscoelastic phone number: (b)(6). All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
 
Event Description
The surgery center reported that the intraocular lens was implanted into the patient's eye when surgeon noticed a black fiber around the optic of the lens. The surgeon removed the fiber with kelman forceps. The doctor is unsure where the fiber came from and whether it was from inside of the 1mtec30 cartridge or from the viscoelastic. The lens remains implanted in the eye to date. There was a five (5) minutes delay in procedure. It was noted that the customer used a non-johnson & johnson viscoelastic brand. The surgeon did not keep the fiber, but the cartridge is available. 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 Key9313834
MDR Text Key178746907
Report Number2648035-2019-01203
Device Sequence Number1
Product Code KYB
Combination Product (y/n)Y
Reporter Country CodeAU
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,Followup
Report Date 01/01/2005,11/06/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/13/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/23/2019
Device Model Number1MTEC30
Device Catalogue Number1MTEC30
Device Lot NumberCD08097
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/13/2020
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? Yes
Date Device Manufactured07/23/2018
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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