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

Model Number	VT585U
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/05/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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.
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 nr-0148919 and capa-010215.

• Brand Name: HEALON ENDOCOAT
• Common Device Name: OVDS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA
• MDR Report Key: 8105318
• Report Number: 3004750704-2018-00058
• Device Sequence Number: 1827582
• Product Code: LZP
• UDI-Device Identifier: 05050474547063
• UDI-Public: (01)05050474547063(17)191031(10)027304
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P110007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/05/2020
• 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: 10/31/2019
• 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 to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/05/2018
• Supplement Date Received by Manufacturer: 03/14/2019; 10/25/2020
• Initial Report FDA Received Date: 11/27/2018
• Supplement Report FDA Received Date: 04/03/2019; 11/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Date Report Sent to FDA: 01/01/2005