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 02/08/2022

Event Type  malfunction  

Manufacturer Narrative

Weight, ethnicity: unknown, information not provided.If implanted, give date: not applicable, the healon is not an implanted product.If explanted, give date: not applicable, the healon is not an implanted product.(b)(6).Device evaluation: the product was not available for evaluation, therefore no testing could be performed.The reported event cannot be confirmed.Manufacturing records review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.A search in complaint system revealed one (1) complaint folder has been received for this production order number.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that after injection of the healon5pro a small particle of plastic was observe in the left eye which was removed from the patient's eye.Event was observed during implantation or application.There was no incision enlargement, sutures or vitrectomy performed.No delay or no medication was prescribed.Daily activities were not significantly affected and the patient has fully recovered post-op.No further information is available.

• 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: 13670286
• MDR Text Key: 290547045
• Report Number: 3012236936-2022-00553
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Device Identifier: 05050474701663
• UDI-Public: (01)05050474701663(17)231231(10)UJ31024
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 03/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: TV60ML
• Device Catalogue Number: 10276015
• Device Lot Number: UJ31024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2021
• 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
• Patient Sex: Male