MAUDE Adverse Event Report: AMO UPPSALA AB HEALON 5 PRO; AID, SURGICAL, VISCOELASTIC

Model Number TV60ML

Device Problem Contamination (1120)

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

Event Date 08/16/2022

Event Type  malfunction  

Event Description

It was reported that when the healon5 pro ophthalmic viscosurgical device (ovd) was injected, it injected a white particle into the patient's right eye.The doctor removed the particle with forceps.Daily activities were not significantly affected.The incision was not enlarged.No vitrectomy was required.There was no capsule tear and no complications.The end-user did not seek medical attention.There was no delay in procedure.No medication was required.Directions for use were followed and the product has been used before.The patient is doing very well with no complications.No further information was provided.

Manufacturer Narrative

If implanted, give date: not applicable as this is not an implantable device.If explanted, give date: not applicable as this is not an implantable device.Telephone number: (b)(6).The device was not returned for evaluation; therefore, a failure analysis of the complaint device cannot 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, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Correction: after further review, the issue identified from the product investigation was only an operational issue, therefore the investigation code 202 ¿ inappropriate material is being removed.This supplemental report is being submitted to capture this corrected information.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

The product was received for evaluation.Additional information: section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: feb 22, 2023.Section h3: evaluated by manufacturer: yes.Device evaluation: visual inspection of the returned product was performed.Complaint sample consisted of a holder with an attached cannula and a glass cylinder, wrapped in a plastic cover.Plunger rod was not returned for investigation.Approximately 0.5 ml of expellable healon solution was left in the glass cylinder.A particle was observed in the remaining solution which could be related to the customer's observation of foreign material in the solution.It appears that there may be fragmentation on the outer surface of the rubber membrane.Fragmentation occurs when the perforation needle penetrates the rubber membrane during activation of the device.This can release small particles from the rubber membrane into the solution.Fourier transform infrared (ftir) micro-spectroscopic analysis of this material find was carried out.The sample spectrum was compared to a reference database for identification of the material.The material was spectrally similar to a material identified as ¿butyl rubber".Based upon the complaint file, visual and stereomicroscopic observations, the ftir investigation and the customer narrative, the reported issue is confirmed.The material find is spectrally and physically similar to the rubber perforation membrane or the rubber plunger.The inspection of the perforation membrane seems to indicate that there are signs of fragmentation on the outer surface of the rubber membrane.Fragmentation of the perforation membrane during activation of the cylinder is most likely source of the particle.Conclusion: as a result of the investigation the presence of a gray rubber fragmentation particle upon expelling healon solution is a known issue, noncritical, occurring at expected frequencies and has not resulted in any reported patient harm.Johnson & johnson surgical vision will continue to monitor this type of complaint per global complaint trending.Corrected data: upon further review it was noted that "section g4: combination product" field should have been populated with "no" but was inadvertently left blank on the initial mdr; therefore, the information has been corrected in this supplemental mdr report and the following fields have been updated accordingly: section g4: combination product: no.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Correction: after further review, it was discovered that "section b4: date of this report" was inadvertently left blank on the supplemental mdr (3012236936-2022-02362 follow-up # 2), but should have been apr 21, 2023.This supplemental report is being submitted to capture this corrected information.

• Brand Name: HEALON 5 PRO
• Type of Device: AID, SURGICAL, VISCOELASTIC
• Manufacturer (Section D): AMO UPPSALA AB; rapsgatan 7; uppsala, uppsala län 754 5 0; SW 754 50
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 15407577
• MDR Text Key: 306166500
• Report Number: 3012236936-2022-02362
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Device Identifier: 05050474636996
• UDI-Public: (01)05050474636996(17)250531(10)UK31293
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TV60ML
• Device Catalogue Number: 10240015
• Device Lot Number: UK31293
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2022
• 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
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White