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 07/18/2023

Event Type  malfunction  

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.Section e1 - telephone number:(b)(6).Section h3 - other (81): the device 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 device 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 piece of white foreign material was observed entering the eye upon use of healon5 pro.The customer said this has happened a number of times in the past but was never reported by them.The surgeon managed to aspirate the piece of material which delayed the procedure by 2 minutes.The patient was reported as fully recovered.No further information was provided.A separate report is being submitted for the unknown number of unreported events.

Manufacturer Narrative

Additional information: section d9 - device available for evaluation? yes section d9 - date returned to manufacturer: 20-sep-2023 section h3 - device evaluated by manufacturer? yes device evaluation: analysis of the photograph provided by the customer revealed a white speck in the eye.The foreign material found during the operation was received for investigation.The complaint product was not included in the shipment.The material had been placed in a sterile container.Visual inspection and fourier transform infrared spectroscopy (ftir) micro-spectroscopic analysis of this material was carried out.The sample spectrum was compared to a reference infrared (ir) database for identification of the material.The material was spectrally similar to a material identified as ¿rubber membrane material".Based upon the complaint file picture, visual & stereomicroscopic observations, the ftir investigation and the customer narrative, the device problem code dc-foreign material loose was confirmed.The foreign material was spectrally and physically similar to the rubber perforation membrane or the rubber plunger.Coring of the perforation membrane during activation of the cylinder was the most likely source of the particle.This risk is indicated in the product's directions for use (dfu) as follows "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 was no indication of a product quality deficiency.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• 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: 17492546
• MDR Text Key: 321107642
• Report Number: 3012236936-2023-01943
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Public: (01)(17)250731(10)UK31416
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 12/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• 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: 30410400
• Device Lot Number: UK31416
• 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: 11/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2022
• 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