MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. ENDOSOL BALANCED SALT SOLUTION

Catalog Number 15020

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Endophthalmitis (1835)

Event Date 11/20/2021

Event Type  Injury  

Event Description

It was reported that after a surgery on a patient's left on (b)(6) 2021, the patient developed endophthalmitis two days later, on (b)(6) 2021. During the surgery, several medications had been used, including the endosol. At the time of reporting the patient was being treated with antibiotics at a separate hospital from where the operation was performed. There were no complications noted during the procedure or the following day during his post op follow-up telephone call. The patient stated that his vision had improved during this call. No further information was reported.

Manufacturer Narrative

(b)(6). Product is not returning for evaluation. Therefore, a failure analysis of the product cannot be completed. A review of the device history record, labeling, complaint trending, and risk documentation for this device will be performed. Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed. Attempts have been made to obtain missing information. However, to date, no response has been received. All pertinent information available to johnson and johnson surgical vision, inc. Has been submitted.

• Brand Name: ENDOSOL
• Type of Device: BALANCED SALT SOLUTION
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 31 technology drive; irvine CA 92618
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 13027919
• MDR Text Key: 287211096
• Report Number: 3012236936-2021-00303
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 01/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 15020
• Device Lot Number: 21D0204
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 12/17/2021 Patient Sequence Number: 1

Treatment

HEALON PRO LOT UJ31368