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

Model Number	TG85ML
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Endophthalmitis (1835); No Code Available (3191)
Date of Event	06/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the healon gv pro was used on a patient who experienced endophthalmitis.The reporter stated that they do not feel the cause was johnson and johnson related.As endophthalmitis is not self-resolving then medication is expected to have been administered.Therefore, this event has been assessed as reportable.No further information is available at this time.
Additional Manufacturer Narrative
The product testing could not be performed as the product was not returned.The reported complaint could not be verified.The manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed three similar complaints has previously been reported on this batch, all from the same account.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.
Additional 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
• Common Device Name: OVDS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 9242427
• Report Number: 3004750704-2019-00049
• Device Sequence Number: 177935
• Product Code: LZP
• UDI-Device Identifier: 05050474651654
• UDI-Public: (01)05050474651654(17)220430(10)UE31214
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P810031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/06/2020
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: TG85ML
• Device Catalogue Number: 10240014
• Device Lot Number: UE31214
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/02/2019
• Supplement Date Received by Manufacturer: 11/04/2019; 10/25/2020
• Initial Report FDA Received Date: 10/25/2019
• Supplement Report FDA Received Date: 11/19/2019; 11/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 01/01/2005