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 Date 03/05/2019

Event Type  malfunction  

Manufacturer Narrative

If implanted; give date: n/a (not applicable).The healon endocoat is not an implantable device.If explanted; give date: n/a (not applicable).The healon endocoat is not an implantable device; therefore, not explanted.(b)(6).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that upon injecting the healon into patient's eye, a black fiber was found in the ovd (ophthalmic viscoelastic device).Further information provided that a second fiber was found as the doctor injected more ovd into patient's eye.The doctor used forceps to get all the fibers out.The patient was not noted to experience any pain in the process.No additional information provided.

Manufacturer Narrative

Device available for evaluation: yes.Returned to manufacturer on: 3/19/2019.Device returned to manufacturer: yes.Device evaluation: evaluation of the returned units confirmed returned fibers as identified by the customer.Visual evaluation under magnification could not confirm the presence of any particles or fibers observed within the remaining product solution.Characterization of the returned fibers confirmed the material to be composed of cellulose.Visible cellulose fibers are not inherent to the manufacturing process.Due to the opened nature of the return, the source of the returned fiber could not be conclusively confirmed.No manufacturing root cause could be determined.Manufacturing records review: the manufacturing review indicates the lot was manufactured per procedure and meets the product specifications.Review of the complaint database over the past year indicates 5 potentially similar complaints have been received for healon endocoat products.Complaint review indicates there have been no trends identified for particulates within solution for all manufactured syringe products.Conclusion: as a result of this investigation, no specific manufacturing root cause could be determined.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

This correction mdr is being submitted to address inaccurate information 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 (b)(4) and (b)(4).

• Brand Name: HEALON ENDOCOAT
• Type of Device: OVDS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 8466979
• MDR Text Key: 140595155
• Report Number: 3004750704-2019-00006
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Device Identifier: 05050474540354
• UDI-Public: (01)05050474540354(17)210531(10)027341
• 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: 01/01/2005,11/10/2020

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: 05/31/2021
• Device Model Number: VT585
• Device Catalogue Number: VT585
• Device Lot Number: 027341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2019
• 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: 03/05/2019
• Initial Date FDA Received: 03/29/2019
• Supplement Dates Manufacturer Received: 04/09/2019; 10/25/2020
• Supplement Dates FDA Received: 05/07/2019; 11/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1