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

Catalog Number 57550500

Device Problem Contamination (1120)

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

Event Date 03/29/2023

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 healon and the particle were 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 there was a black filament during the injection of the healon viscoelastic into the patient's operative eye.Through follow-up we learned that the intraocular lens (iol) remains implanted and the particle/ filament is not available.The patient outcome is good and no further details are available.

Manufacturer Narrative

Section h3.Device evaluated by manufacturer? yes.Device evaluation: the video provided by the customer was evaluated.The video shows the anterior chamber of an eye being injected with viscoelastic, claimed to be healon endocoat.Two (02) seconds into the video a wavy shape, grayish color fiber like particle of approximately 4 to 4.5 mm in length is observed in the anterior chamber.The video confirmed that there is a black filament present that was aspirated during the injection.Conclusion: no root cause was identified.This complaint type appears to be isolated to the single syringe from the lot.These types of events will continue to be monitored through tracking and trending.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): 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: 16773339
• MDR Text Key: 313809235
• Report Number: 3012236936-2023-00911
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Public: (01)(17)250331(10)029701
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 10/03/2023

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 Catalogue Number: 57550500
• Device Lot Number: 029701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/29/2023
• Initial Date FDA Received: 04/19/2023
• Supplement Dates Manufacturer Received: 09/18/2023
• Supplement Dates FDA Received: 10/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2022
• 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