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

Model Number VT585

Device Problem Contamination (1120)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Date of event: exact date unknown, only that is occurred in the week prior to reporting the event.If implanted; give date: n/a (not applicable).Ovd is not an implantable device.If explanted; give date: n/a (not applicable).Ovd is not an implantable device; therefore, not explanted.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that black fibers came out from model vt585 healon endocoat ovd (ophthalmic viscoelastic device) while dispensing it into the patient's eye.The surgeon stated the fiber did not come out until he had plunged most of the viscoelastic out.The fiber was without any adverse event or patient issues.The procedure was completed successfully.No additional information provided.

Manufacturer Narrative

Device available for evaluation: yes.Returned to manufacturer on: 12/17/2018.Device returned to manufacturer: yes.Device evaluation: one opened unit of healon endocoat, lot 027424 was received for evaluation.An assembled, partially used syringe was received, along with a small wipe containing a small, dark fiber (approx.1-2 mm 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.Manufacturing records: the manufacturing records for the product was reviewed.The product was manufactured and released according to specification.There have been no similar particulate complaints for lot number 027424 at the time of this review.Trending review: complaint review also indicates that there have been no trends identified particulates within solution for all lifecore manufacture syringe products.No manufacturing root cause could be determined.Evaluation of the returned unit confirmed the presence of a fiber, however, due to the opened nature of the return, the source of the fiber could not be conclusively confirmed.(b)(4) the review indicates the lots were manufactured per procedure and meet the product specifications.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 92705
• MDR Report Key: 8092412
• MDR Text Key: 128031394
• Report Number: 3004750704-2018-00057
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Device Identifier: 05050474540354
• UDI-Public: (01)05050474540354(17)210331(10)027424
• 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,foreig
• 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: 11/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: VT585
• Device Catalogue Number: VT585
• Device Lot Number: 027424
• 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
• Date Manufacturer Received: 10/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1