MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. - US HEALON ENDOCOAT; AID, SURGICAL, VISCOELASTIC

Model Number VT585

Device Problem Contamination (1120)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/27/2023

Event Type  malfunction  

Manufacturer Narrative

Section e1 - telephone number: (b)(6).Section h3 - other (81): the healon endocoat was not returned for evaluation.Therefore, a failure analysis of the complaint device could not be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review and possible product return and evaluation, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that a blue/black fiber was noticed in the healon endocoat during the implantation/application in a patient's eye.Through follow-up, we learned that the patient was fine and unaffected.The foreign material was successfully removed from the eye and no further information was provided.This issue occurred twice on the same day with two different patients.A separate report is being submitted for the other patient involved.

Manufacturer Narrative

Additional information: section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: 13-dec-2023.Section h3: device evaluated by manufacturer? yes.Device evaluation: video provided was evaluated.It was observed that a dark thin particle was present during application.Returned product was evaluated.No additional particles or fibers were observed in either of two syringes returned to lifecore.The complaint indication could not be confirmed through this return evaluation.Overall, it is noted that a dark thin fiber like particle was present during the usage of this device.However, it cannot be confirmed it was from the syringe or cannula used during the procedure or if it were introduced in the clinical setting.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: HEALON ENDOCOAT
• Type of Device: AID, SURGICAL, VISCOELASTIC
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE, INC. - US; 7500 centurion parkway; jacksonville FL 32256
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 18179024
• MDR Text Key: 328644429
• Report Number: 3012236936-2023-02752
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Device Identifier: 05050474540354
• UDI-Public: (01)05050474540354(17)251031(10)030140
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: P810031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VT585
• Device Catalogue Number: VT585
• Device Lot Number: 030140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/30/2023
• Initial Date FDA Received: 11/20/2023
• Supplement Dates Manufacturer Received: 01/23/2024
• Supplement Dates FDA Received: 01/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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