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

Model Number TV60ML

Device Problem Contamination (1120)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/10/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Product testing could not be performed because the product was not returned.The complaint cannot be confirmed.Manufacturing record review for healon 5 pro, lot# uh31240 was conducted.Results revealed no deviation is reported in the manufacturing record related to reported complaint.A search of complaints related to lot number # uh31240 was performed.One related complaint was found.As a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was initially reported issues with healon 5 pro.Customer found white particle in 2-3 units, only one product was kept.The issue occurred during the implantation phase.Through follow-up, we learnt that 2 products were involved, and there was patient contact.For this report the particle was transferred into the patient¿s eye and the surgeon discovered it when she was filling-up the chamber before phaco.No extra surgery or medication was required.Everything went fine for the patient.The product involved in this case was not kept.No further information has been provided.This report is for patient #1.A separate report is being submitted for patient #2.

• 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
• Manufacturer (Section G): JOHNSON & JOHNSON SURGICAL VISION, INC.; rapsgatan; uppsala 751 8 2; SE 751 82
• Manufacturer Contact: somyata nagpal ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478200
• MDR Report Key: 10988210
• MDR Text Key: 222157514
• Report Number: 3004750704-2020-00065
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Device Identifier: 05050474701632
• UDI-Public: (01)05050474701632(17)230430(10)UH31240
• Combination Product (y/n): Y
• Reporter Country Code: DK
• PMA/PMN Number: P810031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: TV60ML
• Device Catalogue Number: 10290015
• Device Lot Number: UH31240
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1