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

Model Number VT585

Device Problem Contamination (1120)

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

Event Date 11/22/2019

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi#): unknown, as lot number was not provided.Expiration date: unknown, as lot number was not provided.If implanted, give date: not applicable as this is not an implantable device.  if explanted, give date: not applicable as this is not an implantable device.  device manufacture date: unknown as lot number was not provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported by the surgeon that a foreign body was injected when injecting healon endocoat into the patient¿s eye.The surgeon aspirated the debris before proceeding to the cataract extraction.There was no delay in procedure.Patient outcome is noted to be normal.No additional information provided.

Manufacturer Narrative

Device evaluation: due to the unknown lot numbers, and the product not being returned, no investigation is possible at this time.A review of the complaint database indicates that there have been potentially similar reports related to particulates within product for all healon endocoat syringe products within the past year.Previous investigations have determined the root cause was not likely related to the manufacturing process.The reported complaint was not confirmed.Manufacturing records review: the manufacturing records for the product were not reviewed as lot number is unknown.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.H3 other text : placeholder.

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.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 9537270
• MDR Text Key: 188717103
• Report Number: 3004750704-2020-00001
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Public: (01)
• 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: 01/01/2005,11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VT585
• Device Catalogue Number: HEALON ENDOCOAT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• 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
• Patient Age: 66 YR