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 07/07/2022

Event Type  malfunction  

Manufacturer Narrative

Implant/explant date: not applicable as the viscoelastic 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.The ophthalmic viscosurgical device (ovd) was allowed to acclimatize fully to operating room temperature.The procedure was successfully completed.There was no reported patient injury.

Manufacturer Narrative

Additional information: section d9: device available for evaluation? yes.Section d9: returned to manufacturer on: aug 6, 2022.Section h3: device evaluated by manufacturer¿ yes.Device evaluation: this investigation was initially completed with no sample return.2 images of the alleged foreign material were provided by the customer.Analysis of the images depict phenomena inside the eye.No information regarding the material or origin of the phenomena can be determined from the images.Due to the quality of the provided images it cannot be determined whether the phenomena are foreign material, air bubbles, or lens material.No issue can be confirmed.The images cannot be associated with the three complaint files or four reported lot numbers.The product was subsequently received at the evaluation site and was reopened in order to document the results of product evaluation.The product was subsequently received at the evaluation site and was reopened in order to document the results of product evaluation.Complaint sample consisted with a glass cylinder and a plunger rod attached at the bottom of it.Approximately 0.1ml of expellable healon solution left in the cylinder.No other product samples were provided.As no material finds were found within the complaint sample, no instrumental analysis for identification of any foreign material was carried out.The material finds observed by the customer were not returned for analysis.Visual & stereomicroscopic investigations have not observed any non conformity in the returned product which could explain the customer's report.Based on the information obtained, product deficiency cannot be confirmed.The observed material cannot be characterized based on provided images.Without material sample return, no further information can be obtained.Johnson & johnson surgical vision will continue to monitor this type of complaints per global complaint trending.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: 15142675
• MDR Text Key: 304724431
• Report Number: 3012236936-2022-02047
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Device Identifier: 05050474651654
• UDI-Public: (01)05050474651654(17)240228(10)UJ31132
• 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,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2024
• Device Model Number: TG85ML
• Device Catalogue Number: 10240014
• Device Lot Number: UJ31132
• 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: 01/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2021
• 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