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 12/12/2022

Event Type  malfunction  

Event Description

It was reported that the ophthalmic viscosurgical device (ovd) had a white substance that was seen entering the eye.The intraocular lens (iol) in use was inserted and removed during the same procedure due to the ovd issue.Account indicated that the directions for use were followed.There was no medical intervention or surgical intervention required.Patient status is unknown.No further information was provided.

Manufacturer Narrative

Age, weight, ethnicity: unknown/ not provided.If explanted; give date: not applicable as the healon5 pro is not an implantable device.If explanted; give date: not applicable as the healon5 pro is not an implantable device.Therefore, it was not explanted.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 were made to obtain the missing information as well as additional information regarding the complaint; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• 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: 16109503
• MDR Text Key: 308543545
• Report Number: 3012236936-2023-00048
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Device Identifier: 05050474701663
• UDI-Public: (01)05050474701663(17)250731(10)UK31403
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2023
• 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: 10276015
• Device Lot Number: UK31403
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2022
• 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
• Treatment: IOL, UNKNOWN SERIAL #.