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U.S. Department of Health and Human Services

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

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JOHNSON & JOHNSON SURGICAL VISION, INC. ENDOSOL BALANCED SALT SOLUTION Back to Search Results
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.
 
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Brand NameENDOSOL
Type of DeviceBALANCED 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 Key13027919
MDR Text Key287211096
Report Number3012236936-2021-00303
Device Sequence Number1
Product Code KYB
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
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 Received12/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number15020
Device Lot Number21D0204
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received01/04/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/02/2021
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
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