MAUDE Adverse Event Report: AMO UPPSALA AB UNK-OVD_HEALON PRO; AID, SURGICAL, VISCOELASTIC

Model Number UNKNOWN

Device Problem Contamination (1120)

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

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 b3 - date of event: exact date unknown, in the weeks prior to the report date.Section d4 - model number: unknown, as product lot number was not provided.Section d4 - catalog number: unknown, as product lot number was not provided.Section d4 - lot number: unknown/ not provided.Section d4 - expiration date: unknown, as product lot number was not provided.Section d4 - udi number: unknown, as product lot number was 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: email address: unknown/not provided, as information was asked but it was not provided.Section e1 - telephone number: (b)(6) section h4 - device manufacture date: unknown, as product lot number was not provided.Device evaluation: the product was not returned for evaluation.Therefore, a failure analysis of the complaint product could not be performed.Manufacturing record evaluation: the manufacturing records for this product could not be reviewed as no lot number was provided.Complaint history were not reviewed since the lot number is unknown.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.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.

Event Description

It was reported that there were issues with units of healon pro and potentially also healon gv pro.During the last few weeks, the doctor had noticed some small, white particles in the healon.Mostly smaller than 1mm, which looked like some kind of foam/rubber/plastic material.Up until now, the doctor noticed 1 particle each time per healon syringe.Initially it was checked if it was from the cover of the table.It was then observed, that it was obviously caused by healon.The particles were too small to collect in the anterior chamber.It was possible to clean the white particles with the irrigation/aspiration (i/a) procedure.The physician had never noticed these particles before.We learned through follow up that it was unknown how many patients were affected as it was not counted or reported.Patients were reported as doing fine, the physician was able to aspirate the particle each time it happened.There was no material available for investigation.No further information was provided.

• Brand Name: UNK-OVD_HEALON 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: 17477334
• MDR Text Key: 321541502
• Report Number: 3012236936-2023-01908
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Public: (01)(10)UNKNOWN
• 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: Physician
• Type of Report: Initial
• Report Date: 08/07/2023

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: UNKNOWN
• Device Catalogue Number: UNK-OVD_HEALON PRO
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/13/2023
• Initial Date FDA Received: 08/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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