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 07/22/2022

Event Type  malfunction  

Event Description

It was reported that upon injecting the ovd (ophthalmic viscoelastic device) into the patient¿s operative eye, the surgeon found a white substance that was released from the ovd needle.The substance was removed immediately.No impact to patient.The daily activities were not significantly affected.The patient has fully recovered.No further information is available.

Manufacturer Narrative

Age or date of birth,weight and ethnicity: unknown/ not provided.Patient information cannot be provided due to personal data privacy legislation/policy.If implanted, give date: n/a.The ovd (ophthalmic viscoelastic device) is not an implantable device.If explanted, give date: n/a.The ovd (ophthalmic viscoelastic device) is not an implantable device; therefore, not explanted.Initial reporter telephone number: (b)(6) the device was 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.Attempts have been made to obtain missing information; however, no definitive response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Additional information: section d9: device available for evaluation: yes.Date returned to manufacturer: 21 nov 2022.Section h3: device evaluated by manufacturer: yes.Device evaluation: a non johnson & johnson cannula was provided for evaluation and dried healon was observed at the cannula hub and tip.Although foreign material was observed in video provided by the customer, the complaint issue could not be confirmed upon evaluation.The foreign particle was not returned for evaluation/identification.The reported issue could not be confirmed.Please note that the information reported in sections d2 (common device name), h.6 (health effect -clinical code and medical device problem code) and section g.1 (manufacturer contact e-mail) is information that remains unchanged from the initial emdr report.All pertinent information available to johnson & 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: 15341427
• MDR Text Key: 305378797
• Report Number: 3012236936-2022-02171
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Device Identifier: 08806948000216
• UDI-Public: (01)08806948000216(17)241130(10)UJ31666
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P810031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2022
• 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: 10236012
• Device Lot Number: UJ31666
• 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: 05/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/31/2021
• 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