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

Model Number TG85ML

Device Problem Contamination (1120)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/04/2019

Event Type  malfunction  

Manufacturer Narrative

Age/date of birth: unknown/ not provided.Sex/gender: unknown/ not provided.If implanted; give date: n/a (not applicable).Healon is not an implantable device.If explanted; give date: n/a (not applicable).Healon is not an implantable device; therefore, not explanted.First name: unknown/ not provided.(b)(6).Device evaluation: the helaon product was not returned for evaluation as it was discarded after use; therefore, product testing could not be performed, and the customer's reported complaint could not be verified.Manufacturing record evaluation: the manufacturing records for the healon were reviewed and no deviation was found.The product was manufactured and released according to specification.A search in complaint system revealed that two similar complaints for this order number have been received.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported complaint could not be verified.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the product is difficult to remove at the end of the procedure and causes white debris between the lens and the capsule.Surgeon does not know where the debris are from.This leads to pre and post-operative inconvenience.No additional information was provided.This report is two (2) out of two.

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 GV 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: 9292403
• MDR Text Key: 186750730
• Report Number: 3004750704-2019-00073
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Device Identifier: 05050474651593
• UDI-Public: (01)05050474651593(17)220531(10)UE31364
• 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
• Report Date: 01/01/2005,11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2019
• 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: TG85ML
• Device Catalogue Number: 10270514
• Device Lot Number: UE31364
• 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