MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. HEALON 5 PRO; OVDS

Model Number TV60ML

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem No Code Available (3191)

Event Date 06/10/2020

Event Type  Injury  

Manufacturer Narrative

If implanted, give date: not applicable as this is not an implantable device.If explanted, give date: not applicable as this is not an explantable device.(b)(4).Device evaluation: product testing could not be performed as the product was not returned.The reported complaint could not be verified.Manufacturing record review: the manufacturing records for the product were reviewed and no deviation related to current complaint is reported in the manufacturing record.The product was manufactured and released according to specifications.A search in complaint system revealed that there was 1 other complaint related to the reported issue.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.

Event Description

It was reported that the healon product coagulated in the left eye of a patient and they could not get it out.The doctor had to use interior vitrector to remove the material from the eye.Even with high vacuum it occluded the handpiece.They had to make an enlarged incision and use sutures on the patient.The doctor thinks that he took care of the issue and no surgical or medical interventions are required in the future.It was indicated that the patient seemed to be fine and there was no apparent adverse affects.The patient was sent home directedly after the surgery.The account reported the syringe was thrown away.No additional information was provided.

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 5 PRO
• Type of Device: OVDS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 10248308
• MDR Text Key: 201274110
• Report Number: 3004750704-2020-00032
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Device Identifier: 05050474636996
• UDI-Public: (01)05050474636996(17)221130(10)UE31773
• Combination Product (y/n): Y
• PMA/PMN Number: P810031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: TV60ML
• Device Catalogue Number: 10240015
• Device Lot Number: UE31773
• 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 Outcome(s): Required Intervention
• Patient Age: 65 YR