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

Model Number TG85ML

Device Problem Contamination (1120)

Patient Problem Inflammation (1932)

Event Date 12/01/2022

Event Type  Injury  

Event Description

It was reported there was foreign material when healon gv pro was injected into the patient's eye.The patient suffered from inflammation after the surgery and received steroids and antibiotics to clear it up.There was no delay in treatment or other interventions provided.No further information was provided.

Manufacturer Narrative

Patient info: unknown/not provided.Patient information cannot be provided due to personal data privacy legislation/policy.Implant date: not applicable as this is not an implantable device.Explant date: not applicable as this is not an implantable device.Reporter last name: unknown.Reporter email address: unknown/ not provided.(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.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: 16035895
• MDR Text Key: 306015082
• Report Number: 3012236936-2022-03163
• Device Sequence Number: 1
• Product Code: LZP
• Combination Product (y/n): N
• Reporter Country Code: MY
• 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: Physician
• Type of Report: Initial
• Report Date: 12/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TG85ML
• Device Catalogue Number: 10281014
• Device Lot Number: UK31134
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/02/2022
• Initial Date FDA Received: 12/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2022
• 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
• Patient Outcome(s): Required Intervention