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

Model Number TH85ML

Device Problem Contamination (1120)

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

Event Date 05/17/2023

Event Type  malfunction  

Event Description

It was reported that a small thread came out with healon during intraocular lens (iol) implantation and was introduced into the patient's eye.The small thread was removed from the eye.The patient is reportedly doing fine.No further information was provided.

Manufacturer Narrative

Section a2, a4 and a5: information unknown/ not provided.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: n/a.Healon is not an implantable device.Section d6b - explant date: n/a.Healon is not an implantable device.Section e1 - telephone number: (b)(6).Section h3 - other (81): the healon or the thread were 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 and johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Additional information: section d9 - device available for evaluation? yes.Section d9 - date returned to manufacturer: (b)(6) 2023.Section h3 - device evaluated by manufacturer? yes.Device evaluation: the complaint sample received consisted of an open product box with the directions for use and an activated syringe with no expellable healon solution in it.Upon visual inspection of the returned product, no observations related to the customer's narrative were found.The reported issue could not be verified.The reported foreign material was not returned for evaluation; therefore, instrumental analysis could not be performed.The reported issue was not confirmed.Based on the information obtained, there is no indication of product malfunction or product deficiency.These types of events will continue to be monitored.Conclusion: 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 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: 17114314
• MDR Text Key: 317444782
• Report Number: 3012236936-2023-01301
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Device Identifier: 05050474761360
• UDI-Public: (01)05050474761360(17)251130(10)UK31829
• Combination Product (y/n): N
• Reporter Country Code: DA
• 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: 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TH85ML
• Device Catalogue Number: 10311012
• Device Lot Number: UK31829
• 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: 11/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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