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

Model Number 10270012

Device Problem Contamination (1120)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/20/2019

Event Type  malfunction  

Manufacturer Narrative

Age/date of birth: unknown/ not provided.Sex/gender: unknown/ not provided.(b)(6).If implanted; give date: viscoelastic product is not an implantable device.If explanted; give date: viscoelastic product is not an implantable device; therefore, not explanted.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that during a cataract surgery, after a perfect dfu preparation, the doctor observed a black string came around after implantation.It has been gone away by ia.No patient injury reported.Surgeon was not sure if particle was related to the intraocular lens, model pcb00 implanted or the viscoelastic (ovd) model healon pro used during procedure.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.This report is related to the product, viscoelastic healon pro.

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.

Manufacturer Narrative

G9: correction: in review, of medwatch 3004750704-2019-00107 and per new information received, this event has been assessed not reportable due the fact that customer did not longer belief that particles came from a jnj product.There will be no more information provided for mfg reporting no.3004750704-2019-00107.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.

• Brand Name: HEALON 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: 9467373
• MDR Text Key: 188716121
• Report Number: 3004750704-2019-00107
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Device Identifier: 05050474609631
• UDI-Public: (01)05050474609631(17)220831(10)UE31547
• Combination Product (y/n): Y
• PMA/PMN Number: P810031
• 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: 12/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: 10270012
• Device Catalogue Number: HEALON PRO 0,85 ML
• Device Lot Number: UE31547
• 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