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 Code	Endophthalmitis (1835)
Date of Event	09/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If implanted, give date: not applicable as this device is not an implantable device.If explanted, give date: not applicable as this device is not an explantable device.Concomitant medical products: intraocular lens, model aab00, serial unknown and phaco handpiece, sn (b)(4).Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a patient developed endophthalmitis post-surgery where healon gv pro was used.The reporter indicated that they do not have any reason to believe that the cause was johnson & johnson (j&j) product related.No additional information was provided.This report captures the event for healon gv pro.A separate report is being submitted for each j&j device used in this case.
Additional Manufacturer Narrative
Device evaluation: the product evaluation could not be performed as no sample was returned for investigation.The reported complaint cannot be confirmed.Manufacturing record evaluation: a manufacturing record review was performed and no deviation related to this complaint is reported in the manufacturing record.The product was manufactured and released according to specification.A search in complaint system revealed that three similar complaints have previously been reported on this batch, all from the same account.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.
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 (b)(4) and (b)(4).

• 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: 9254189
• Report Number: 3004750704-2019-00053
• Device Sequence Number: 14075150
• 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: 10/30/2019
• Supplement Report FDA Received Date: 11/15/2019; 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