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

Model Number TG85ML

Device Problem Product Quality Problem (1506)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Age/date of birth: unknown, information not provided.Gender/sex: unknown, information not provided.Date of event: unknown, not provided.Catalog number: unknown, as the lot number was not provided.Lot number: unknown, information not provided.: udi number: udi number is unknown, as the 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.  expiration date: unknown, as lot number was not provided.(b)(4).The product is not returning for evaluation, 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.Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision has been submitted.

Event Description

It was reported that surgeon has issues with healon gv pro.Reportedly surgeon is having issues with the way healon gv pro behaves when he uses it to elevate lens pieces after cracking.With the old gv the pieces pop up nicely and he can quickly remove the gv and then the pieces.He cannot do this with gv pro and the pieces tend to feel more stuck.Additionally, in one of the cases he had a dropped nucleus and he believes this was because of the gv pro.The patient has been referred to a retinal specialist to have the nucleus removed.Additional information was received and it was learnt that surgeon had to alter his technique as he had to spend more time on removal and on occasion he says that he can still see some gv behind the lens but decides to leave it there because he is not willing to go behind the lens to get it out.Reportedly some patients were provided with diamox to help prevent post op spike that could be caused due to healon gv that was left behind the lens.This report will capture information for the patient who was referred to retinal specialist.Another report is being submitted for the patients who were provided with diamox to prevent post op spike that could be caused due to healon gv that was left behind the lens.No further information provided.

Manufacturer Narrative

Additional information: section h6: conclusion code 4316 is provided as complaint is related to a field action.Section h9: this complaint is part of the recall - report number 2020664-12/02/19-001-r: johnson & johnson surgical vision (jjsv) issued a voluntary recall on november 22, 2019.It has been reported customers have described healon gv pro as behaving differently than the legacy healon gv, especially in regard to the techniques required to remove the product from the eye.An increase of intra-ocular pressure (iop) is reported if there are small amounts of healon gv pro remaining behind the operative eye.This voluntary recall is being initiated due to received reports of healon gv pro being difficult to remove from the eye, leading to increased post-operative iop requiring additional intervention.Potential clogging of phacoemulsification equipment tubing has also been reported, which may lead to delay in the procedure or ocular injury.There are twenty-one affected lot numbers.The recall notification letter has been sent to all customers instructing them to return the units of healon gv pro from the twenty-one (21) affected lots.Johnson & johnson surgical vision has initiated a corrective and preventative actions (capa) to investigate and address the issue.Action items generated from the capa will be submitted in the future interim report(s) as part of the recall process.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted h3 other text : placeholder.

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 GV PRO
• Type of Device: OVDS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 9421349
• MDR Text Key: 170263224
• Report Number: 3004750704-2019-00094
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Public: (01)(10)UNKNOWN
• Combination Product (y/n): Y
• PMA/PMN Number: P810031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TG85ML
• Device Catalogue Number: HEALON GV PRO
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 10/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 2020664-12/02/19-001-R
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention