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

Model Number VT585

Device Problem Contamination (1120)

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

Event Date 07/04/2023

Event Type  malfunction  

Event Description

It was reported that the surgeon saw a blue/black fiber in the healon endocoat.The incident occurred during the application and the directions for use where followed.Through follow-up we learned that the fiber was introduced in the patient's eye.The patient is fully recovered and there was no delay in the procedure.No further information was provided.

Manufacturer Narrative

Section a2, a4 and a5: per regulation eu 2016/679 (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Section d6a - implant date: not applicable.Healon is not an implantable device.Section d6b - explant date: not applicable.Healon is not an implantable device; therefore, not explanted.Section e1 - telephone number: (b)(6).Section h3 - other (81): the healon 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.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.

Manufacturer Narrative

Additional information: section d9 - device available for evaluation? yes section d9 - date returned to manufacturer: september 19, 2023 section h3 - device evaluated by manufacturer? yes device evaluation: the product was returned to the manufacturing site for evaluation.The syringe product was received.No remaining fibers were visible in the product that was left unused in the syringe.No further material was returned and no additional evaluation could be performed.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 SURGICAL VISION, INC.; 31 technology drive; irvine CA 92618
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 17417360
• MDR Text Key: 320302723
• Report Number: 3012236936-2023-01814
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Device Identifier: 05050474540354
• UDI-Public: (01)05050474540354(17)250930(10)029846
• 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: 10/11/2023

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: 029846
• 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: 07/05/2023
• Initial Date FDA Received: 07/28/2023
• Supplement Dates Manufacturer Received: 09/21/2023
• Supplement Dates FDA Received: 10/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2022
• 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