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 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: unknown, as information was requested but 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 - telephone number: (b)(6).Section h3 - other (81): the device(s) were not returned for evaluation.Therefore, a failure analysis of the complaint device(s) could not be completed.No serial number was provided for the device(s); therefore, no further investigation can be performed.If there is any further relevant information received, a supplemental medwatch will be filed.Section h4 - device manufacture date: unknown, as product lot number was not provided.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 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 specific incident with the known lot number.

• 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: 17492493
• MDR Text Key: 320759453
• Report Number: 3012236936-2023-01965
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Public: (01)
• 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
• Report Date: 08/09/2023

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/18/2023
• 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