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

Model Number HEALON ENDOCOAT

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

Patient Problem Inflammation (1932)

Event Date 09/25/2020

Event Type  Injury  

Manufacturer Narrative

If implanted; give date: n/a (not applicable).The healon endocoat is not an implantable device.If explanted; give date: n/a (not applicable).The healon endocoat is not an implantable device.The device is not returning for evaluation as it was discarded by the account; therefore, a failure analysis of the complaint device cannot be completed.A review of the device/lot history record and complaint trending 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, no definitive response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that tass case occurred in a patient.Healon pro, lot# uh31179 and healon endocoat, lot# 028612, were used.It was stated that this case was the last case of the day.The patient was treated with moxifloxacin (antibiotic) 6 times a day, durezol q1-2h and medrol dose pack.At last appointment, vision is improving.The customer does not have the product to return for evaluation.Both the healon pro and healon endocoat are kept in the refrigerator until the morning of the case.The temperature log that day did not show any changes in temperature that would be out of the normal range.This report represents the complaint against the healon endocoat.A separate report is being submitted for the healon pro.

• Brand Name: HEALON ENDOCOAT
• Type of Device: OVDS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• Manufacturer (Section G): JOHNSON & JOHNSON SURGICAL VISION, INC.; rapsgatan; uppsala 751 8 2; SE 751 82
• Manufacturer Contact: somyata nagpal ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478200
• MDR Report Key: 10767185
• MDR Text Key: 214104920
• Report Number: 3004750704-2020-00054
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Public: (01)(17)220331(10)028612
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P110007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: HEALON ENDOCOAT
• Device Catalogue Number: 51031000
• Device Lot Number: 028612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR