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

Model Number	HEALON GV
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown, 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 or Problem Description
It was reported that the restriction caused the cannula to pop off a unit of healon gv and the viscoelastic squirted out.There was no patient contact or injury noted, and the problem was not related to use error.No additional information provided.
Additional Manufacturer Narrative
In follow up with the account, it was learned that there was no specific date of surgery for the reported event.It was indicated that they have been noticing a few of the cannulas that come with the healon gv seemed to be clogged or restricted in some way.The following field was updated based on the new information received: initial reporter name and address: email: (b)(6).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information was received and clarified that the event of cannula restriction, popping off the healon gv unit occurred during priming of the device, and not during the procedure.Therefore, based on the additional information received, this event is no longer considered a reportable malfunction.No further information will be provided under medwatch #3004750704-2019-00013.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
This correction mdr is being submitted to address inaccurate information in section f on the xml version of the previous submission caused by a software glitch in the transmission process.The internal non-conformance numbers for this software issue are (b)(4) and (b)(4).

• Brand Name: HEALON
• Common Device Name: OVDS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 8553589
• Report Number: 3004750704-2019-00013
• Device Sequence Number: 373560
• Product Code: LZP
• UDI-Device Identifier: 00385445085417
• UDI-Public: (01)00385445085417(17)211031(10)UD31815
• Combination Product (Y/N): Y
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P810031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/11/2020
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: HEALON GV
• Device Catalogue Number: 10294801
• Device Lot Number: UD31815
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/28/2019
• Supplement Date Received by Manufacturer: 04/29/2019; 05/22/2019; 10/25/2020
• Initial Report FDA Received Date: 04/26/2019
• Supplement Report FDA Received Date: 05/27/2019; 06/17/2019; 11/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005