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

Model Number TH85ML

Device Problem Contamination (1120)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/17/2020

Event Type  malfunction  

Manufacturer Narrative

Age/date of birth: unknown, information not provided.Gender/sex: unknown, information 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.Initial reporter name: unknown, not provided.Phone: (b)(6).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that white particles/foreign material appeared after a little after the healon was being injected into patient's eye to maintain anterior capsule.The particles were aspirated with healon needle and resides within the cannula.The procedure was completed successfully and there was no patient injury reported.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.

Manufacturer Narrative

Section d10.Device available for evaluation? yes; returned to manufacturer on: 5/6/2020.Section h3.Device returned to manufacturer? yes.Device evaluation: sample was received for further evaluation at the manufacturing site for evaluation.Visual inspection was performed, and foreign material was observed in the remaining solution.The reported event is confirmed.Based on the record review and product evaluation, product malfunction can be confirmed.Based upon the results of this investigation, it is indicated that a white material find, consisting of silicone oil, calcium carbonate and a polyolefin, was observed inside the customer¿s cannula which was returned with the healon syringe.Additionally, based upon the complaint narrative that ¿the particles were aspirated with the healon needle and resides within the cannula.¿, then it is likely that the material find found in the cannula hub was that observed by the customer when the healon solution was expelled into the patient¿s eye.As there are no similar materials used in the production of healon pro family products at jjsv manufacturing site, then this investigation has not determined the probable cause/source of the material.However, the only possible sources of the particles are either from syringe components (rubber plunger/membrane), the customer¿s cannula or end-user contamination.This is a single-event issue with unknown origin.Manufacturing record review: a manufacturing record review for healon pro was performed and no deviation related to the complaint is reported in the manufacturing record.A search of complaints related to lot number was performed and no other complaints reported from this batch.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 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: 9951880
• MDR Text Key: 208778109
• Report Number: 3004750704-2020-00030
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Device Identifier: 04987617203481
• UDI-Public: (01)04987617203481(17)221031(10)UE31686
• Combination Product (y/n): Y
• PMA/PMN Number: P810031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: TH85ML
• Device Catalogue Number: 10260012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2020
• 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