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

Model Number TG85ML

Device Problem Contamination (1120)

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

Event Type  malfunction  

Event Description

It was reported that a white particle was noticed inside the patient's eye during the use of healon gv pro viscoelastic.The white particle was aspirated when noticed.Patient is doing fine and has fully recovered.No further detail 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 b3 - date of event: unknown, as information was requested but not provided section d6a - implant date: not applicable.Healon is not an implantable device.Section d6b - explant date: not applicable.Healon is not an implantable device.Section e1 - first/given name: only first initials provided.Therefore, the name remains unknown, as information was requested but not provided.Section e1 - email address: unknown, as information was requested but not provided.Section e1 - telephone number: +(b)(6).Section h3 - other (81): the product 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 the 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: mar 1, 2024, section h3 - device evaluated by manufacturer? yes.Device evaluation: photograph analysis of the image provided by the customer reveals a small white particle in the eye.The reported issue is confirmed.1 of the reported 1 opened tg85ml was received within its original packaging, confirming the reported lot number.The complaint sample consisted of a product box, directions for use (dfu), blister tray, and activated syringe with approximately 0.7 ml of expellable healon solution in it.Upon visual inspection of the remaining healon solution, a suspended particle at the neck region of the glass cylinder was found.The size of the particle was too small to handle.Therefore, fourier transform infrared (ftir) analysis was not done.Signs of coring was observed on the outer surface of the perforation membrane.The perforation membrane inner side looked normal.The reported issue is confirmed.Based on the information obtained, product malfunction and deficiency are not confirmed.The coring or fragmentation of the perforation membrane during activation of the cylinder is a known issue occurring at the frequencies indicated in the risk files.Therefore, this is a known inherent risk of the device and not considered a product defect nor malfunction.This risk is indicated in the product's dfu: "express a small amount of the healon5® pro ovd from the syringe prior to use and carefully examine it during use to avoid injecting minute rubber particles which may be released when the syringe diaphragm is punctured".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 GV PRO
• 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: 18307737
• MDR Text Key: 330675457
• Report Number: 3012236936-2023-03024
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Device Identifier: 05050474761414
• UDI-Public: (01)05050474761414(17)260630(10)UM31463
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/30/2024

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: TG85ML
• Device Catalogue Number: 10310014
• Device Lot Number: UM31463
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/19/2023
• Initial Date FDA Received: 12/11/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/05/2023
• 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