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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 Failure to Eject (4010)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/07/2020
Event Type  Malfunction  
Manufacturer Narrative

Age/ date of birth: unknown, information not provided. Gender/ sex: unknown, information not provided. Expiration date: unknown, information not provided. Serial #: unknown, information not provided. Unique identifier: unknown, information not provided. Implant date: unknown, information not provided. Explant date: unknown, information not provided. Device manufactured date: unknown, information not provided. 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 & johnson surgical vision, inc. Has been submitted.

 
Event Description

It was reported that a aab00 19. 5 diopter intraocular lens (iol) was partially inserted as the iol got stuck in the cartridge and in the incision while attempting to insert it into the eye. The doctor removed the iol with forceps. Another j&j iol was implanted to complete the procedure. Reportedly, there was no patient injury. No further 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 Key9673839
MDR Text Key178029745
Report Number2648035-2020-00112
Device Sequence Number1
Product Code KYB
Combination Product (Y/N)Y
Reporter Country CodeUS
PMA/PMN NumberK081545
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/01/2005,03/24/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/05/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
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? Yes
Date Report Sent to FDA01/01/2005
Event Location No Information
Date Report TO Manufacturer01/10/2005
Date Manufacturer Received03/24/2020
Is this a Reprocessed and Reused Single-Use Device? No

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