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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
Event Date 03/11/2019
Event Type  Malfunction  
Manufacturer Narrative

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. Device evaluation: the device was not returned at the manufacturing site; therefore; product testing could not be performed, and the customer¿s reported complaint could not be verified. Manufacturing record review: the manufacturing records for the intraocular lens were reviewed. The product was manufactured according to specifications. The search revealed that no similar complaint for this production order number has been received. Labeling review: the directions for use (dfu) was reviewed. The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the product. Conclusion: as a result of the investigation there is no indication of a product quality deficiency. All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.

 
Event Description

It was reported that the intraocular lens (iol) was stuck in the cartridge. There was difficulty getting the lens out of the cartridge. The customer confirmed there was patient contact, but there was no harm to the eye. No additional information was provided to johnson & johnson surgical vision.

 
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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 Key8621623
Report Number2648035-2019-00580
Device Sequence Number1
Product CodeKYB
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation
Type of Report Initial
Report Date 01/01/2005,05/17/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/17/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/16/2019
Device MODEL Number1MTEC30
Device Catalogue Number1MTEC30
Device LOT NumberCD09009
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 Received04/19/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/16/2018
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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