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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 11/18/2019
Event Type  Malfunction  
Manufacturer Narrative

Age/date of birth: unknown, information not provided. Gender/sex: unknown, information not provided. Lot number: unknown, information not provided. Unique device identifier (udi #): unknown, as lot number was not provided. Expiration date: unknown, as lot number was not provided. If implanted, give date: not applicable as this is not an implantable device.  if explanted, give date: not applicable as this is not an implantable device.  device manufacture date: unknown as lot number was not provided. All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.

 
Event Description

It was reported that the intraocular lens (iol) had loading issue and was stuck in cartridge, would not advance while inserting. There was patient contact with eye but no medical or surgical intervention were required. Patient is doing fine post-op. No further information 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 Key9759622
Report Number2648035-2020-00183
Device Sequence Number1
Product CodeKYB
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/01/2005,03/16/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/26/2020
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 Received02/27/2020
Is this a Reprocessed and Reused Single-Use Device? No

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