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

Model Number TG85ML

Device Problem Contamination (1120)

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

Event Date 06/29/2022

Event Type  malfunction  

Manufacturer Narrative

Age or date of birth,weight, and ethnicity: unknown; requested but not provided.If implanted; give date: not applicable as the ovd (ophthalmic viscoelastic device) is not an implantable device.If explanted; give date: not applicable as the ovd (ophthalmic viscoelastic device) is not an implantable device.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; however, 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 white specks were noticed in the eye while using the ophthalmic viscosurgical device (ovd).All white specks were successfully removed from the eye with irrigation.The procedure was successfully completed.There was no reported patient injury.No additional information was provided.

Manufacturer Narrative

Additional information: section d9: device available for evaluation? yes.Section d9: returned to manufacturer on: nov 10, 2022.Section h3: device evaluated by manufacturer¿ yes.Device evaluation: the complaint sample consisted of the glass cylinder with the plunger rod attached to it.Approximately 0.5ml expellable healon solution remained in the glass cylinder.A larger air bubble was observed in the healon gv pro solution.There was approximately 0.5ml of expellable healon gv pro solution left in the glass cylinder.The cylinder holder, perforation needle, cannula, blister tray, product box and dfu were not returned.A photo analysis of photo provided by the customer revealed indicated that the reported device problem code of "dc-foreign material - loose" is correct.The solution was clear and free from particles or material finds which could explain the customer's observation and the reported device problem code of "dc-foreign material - loose".No remarks or signs of damaged silicon coating or damaged glass cylinder.Rubber plunger surface was free from particles or material finds which could explain the customer's observation and the reported device problem code.No signs of coring on the outer surface of the rubber membrane were observed.The inner surface of the rubber membrane looks normal.Functional testing was not performed as the complete syringe was not returned for the investigation.As a result of the investigation there is no indication of a product deficiency or product malfunction.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: HEALON GV 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: 15332675
• MDR Text Key: 305378613
• Report Number: 3012236936-2022-02161
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Device Identifier: 05050474651654
• UDI-Public: (01)05050474651654(17)231231(10)UJ31020
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P810031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2022
• 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: TG85ML
• Device Catalogue Number: 10240014
• Device Lot Number: UJ31020
• 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: 03/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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