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

Model Number TG85ML

Device Problem Contamination (1120)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/28/2020

Event Type  malfunction  

Manufacturer Narrative

Age/date of birth: unknown/ not provided.Sex/gender: unknown/ not provided.If implanted; give date: n/a.The healon is not an implantable device.If explanted; give date: n/a.The healon is not an implantable device; therefore, not explanted.Phone: (b)(6).The healon is not returning for evaluation as it was discarded, therefore, 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.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that there was a crust in the viscoelastic material after injection into the patients eye.This occurred in 3 out of 8 patients.Through follow-up we learned that the crusted material was aspirated during the initial procedure, no issues reported, and no secondary procedure required.This report is for the third of three unidentified patient, and separate reports will be submitted for the other two patients.No additional information was provided.

• 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
• 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 Key: 10901701
• MDR Text Key: 218201405
• Report Number: 3004750704-2020-00058
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Device Identifier: 05050474651609
• UDI-Public: (01)05050474651609(17)230430(10)UH31226
• Combination Product (y/n): Y
• Reporter Country Code: BE
• PMA/PMN Number: P810031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: TG85ML
• Device Catalogue Number: 10270014
• Device Lot Number: UH31226
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1