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 09/25/2020

Event Type  malfunction  

Manufacturer Narrative

Gender/sex: unknown, information not provided.Date of event: 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 explantable device.Telephone number: (b)(6).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 no complaints have previously been reported on this batch.Conclusion: 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 reported that a whitish particle was found in patient¿s anterior chamber (ac) right after injection of healon.The particle was withdrawn by the surgeon immediately but it was suspected that the particle dissolved in the balanced salt solution (bss) subsequently.The surgery was performed uneventfully.The doctor will monitor the patient.No further information was reported.

• 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: 10783120
• MDR Text Key: 214536771
• Report Number: 3004750704-2020-00055
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Device Identifier: 05050474609679
• UDI-Public: (01)05050474609679(17)220531(10)UE31332
• Combination Product (y/n): Y
• Reporter Country Code: HK
• PMA/PMN Number: P810031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: TV60ML
• Device Catalogue Number: 10270015
• Device Lot Number: UE31332
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2019
• 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