MAUDE Adverse Event Report: JOHNSON AND JOHNSON SURGICAL VISION HEALON ENDOCOAT; OVDS

Model Number VT585

Device Problem Contamination (1120)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/17/2018

Event Type  malfunction  

Manufacturer Narrative

If implanted; give date: n/a (not applicable).If explanted; give date: n/a (not applicable).The device is not returning for evaluation as it was discarded by the account; therefore, a failure analysis of the complaint device cannot be completed.A review of the device/lot 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.Attempt (s) 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, inc.Has been submitted.

Event Description

It was reported that while a doctor was performing a case using healon endocoat a dark blue fiber was observed coming out with the viscoelastic into the eye.The doctor removed the fiber using forceps.It seemed apparent to the doctor and scrub that it did not come from the outside of the syringe.No patient harm was reported, and the issue was resolved.The customer cannot confirm but they think the fiber came from the viscoelastic.Follow-up confirmed that the product and debris were both discarded.

Manufacturer Narrative

The internal non-conformance numbers for this software issue are (b)(4) and capa-(b)(4).

Manufacturer Narrative

Device available for evaluation: yes, returned to manufacturer on 10/08/2018.Device returned to manufacturer: yes.Device evaluation: one unit of healon endocoat, lot 027443 was returned for evaluation.This revealed an assembled, partially used syringe, cannula, and cannula guard were received.Visual evaluation of the returned syringe unit could not identify the presence of fibers.No fiber was returned with the syringe unit.The complaint indication was not confirmed through the visual evaluation of this unit.Manufacturing record review: no manufacturing root cause could be determined.(b)(4).There have been no similar particulate complaints for lot number 027443 at the time of this review.All release particulate test meets the product specifications.Labeling review: the labeling review was completed.The directions for use (dfu) adequately provide instructions, precautions, along with warnings for the proper use and handling of the product.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: HEALON ENDOCOAT
• Type of Device: OVDS
• Manufacturer (Section D): JOHNSON AND JOHNSON SURGICAL VISION; santa ana CA
• MDR Report Key: 7970931
• MDR Text Key: 124320152
• Report Number: 3004750704-2018-00052
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Public: (01)(17)200131(10)027443
• Combination Product (y/n): Y
• PMA/PMN Number: P110007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: VT585
• Device Catalogue Number: VT585U
• Device Lot Number: 027443
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2018
• 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
• Patient Sequence Number: 1