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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. HEALON OVDS

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JOHNSON & JOHNSON SURGICAL VISION, INC. HEALON OVDS Back to Search Results
Model Number HEALON GV
Device Problems Mechanical Problem (1384); Separation Problem (4043)
Patient Problem No Patient Involvement (2645)
Event Type  Malfunction  
Manufacturer Narrative

Date of event: unknown, 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. An attempt has been made to obtain missing information; however, to date, no response has been received. All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.

 
Event Description

It was reported that few of the cannulas that come with the healon gv seemed to be clogged or restricted in some way. No patient injuries or contact has occurred as our surgical tech primes the cannula before surgery noticing it. For most cases cannula were opened and all went well but for few of them a new healon gv had to be opened because the restriction caused the cannula to pop off and the healon was wasted. No further information provided.

 
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Brand NameHEALON
Type of DeviceOVDS
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.
rapsgatan
uppsala 751 8 2
SE 751 82
Manufacturer Contact
somyata nagpal
1700 east st. andrew place
santa ana, CA 92705
7142478200
MDR Report Key8652334
MDR Text Key147638636
Report Number3004750704-2019-00016
Device Sequence Number1
Product Code LZP
Combination Product (Y/N)Y
Reporter Country CodeUS
PMA/PMN NumberP810031
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 01/01/2005,06/17/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/29/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberHEALON GV
Device Catalogue Number10294801
Device LOT NumberUD31908
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
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 Received05/22/2019
Date Device Manufactured12/31/2018
Is this a Reprocessed and Reused Single-Use Device? No

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