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 03/23/2022

Event Type  malfunction  

Manufacturer Narrative

Age, weight and ethnicity: unknown/ not provided.Implant date : not applicable as this is not an implantable device.Explant date : not applicable as this is not an implantable device.Initial reporter telephone number: (b)(6).It was indicated that the device is not returning 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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that when ophthalmic viscosurgical device (ovd) was inserted into the patient's operative eye and white specks were seen in the eye.The surgeon only noticed the white specks in ovd when injected into eye.The ovd was completely removed from the eye.The white speck injected is not available as it was removed by phaco machine.The vial of the ovd is available for return.Patient information cannot be provided due to personal data privacy legislation/policy.No further information is available.

Manufacturer Narrative

Section d9: device available for evaluation: yes date returned to manufacturer: 28 june 2022.Section h3: device evaluated by manufacturer: yes.Device evaluation: the product was returned to the manufacturing site for evaluation.The visual inspection of the returned complaint sample did not confirm the presence of material finds as reported by the customer nor was a product defect or deficiency found.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson & 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: 14138980
• MDR Text Key: 290560743
• Report Number: 3012236936-2022-01028
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Device Identifier: 05050474651692
• UDI-Public: (01)05050474651692(17)240531(10)UJ31380
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TG85ML
• Device Catalogue Number: 10281014
• Device Lot Number: UJ31380
• 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: 07/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2021
• 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