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

Model Number VT585U

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/05/2018

Event Type  malfunction  

Manufacturer Narrative

If implanted, explanted, give date: not applicable, as the product is not implantable.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that a black hair came out of a vt585u healon endocoat into the patient's anterior chamber (right eye).The foreign particle was successfully removed.There was no incision enlargement, no vitrectomy, and no sutures used.Reportedly, there was no patient injury and the patient is doing fine post-operatively.No additional information was provided.

Manufacturer Narrative

One opened unit of healon endocoat was received for evaluation on 12/17/2018.An assembled, partially used syringe was received, along with a swab containing a small, dark fiber (approx.2mm in length).Visual evaluation of the syringe could not identify any particulates/fibers within the remaining solution.Due to the returned opened condition and evidence of use, the source and origin of the fiber cannot be determined.The customer's reported event could not be confirmed.The manufacturing records were reviewed.There were no procedural nonconformities or interventions in the manufacturing of the lot that would indicate an elevated potential for fibers in the product solution.The product met the requirements for visible particulates for sub-assembly as well as the final product testing.There were no trends related to particulates for the raw material syringe, stopper, or cannula lots used in the manufacture of the product.There has been one similar complaints received for this lot.Complaint review indicates there have been no trends identified for particulates within solution for syringe products manufactured by this manufacturer.Review of components used to manufacture the lot, showed no complaint trends for the syringe stopper, or cannula raw material lots.Based on the results of the investigation, no product deficiency was identified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

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 nr-0148919 and capa-010215.

• Brand Name: HEALON ENDOCOAT
• Type of Device: OVDS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA
• MDR Report Key: 8105318
• MDR Text Key: 128388459
• Report Number: 3004750704-2018-00058
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Device Identifier: 05050474547063
• UDI-Public: (01)05050474547063(17)191031(10)027304
• Combination Product (y/n): Y
• PMA/PMN Number: P110007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: VT585U
• Device Catalogue Number: VT585U
• Device Lot Number: 027304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2018
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 11/05/2018
• Initial Date FDA Received: 11/27/2018
• Supplement Dates Manufacturer Received: 03/14/2019; 10/25/2020
• Supplement Dates FDA Received: 04/03/2019; 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 80 YR