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

Model Number HEALON GV

Device Problem Contamination (1120)

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

Event Type  malfunction  

Manufacturer Narrative

Age or date of birth, weight and ethnicity: unknown, information not provided.Date of event: unknown, not provided, but the best estimate date is during february 2022.Lot number: unknown, information not provided.Expiration date: unknown, as the lot number was not provided.Udi number: unknown, as the lot number was not provided.If implanted, give date: not applicable as healon is not an implantable device.Explant date: if explanted, give date: not applicable as healon is not an implantable device; therefore, not explanted.Device evaluated by mfr: the device was not returned for analysis as the device was discarded.Therefore, a failure analysis of the complaint device cannot be completed.As the lot number is unknown no further investigation can be performed.If there is any relevant information received, a supplemental medwatch will be filed.Device manufacture date: unknown as lot number was not provided.Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that fibers were coming out of the cannulas of the healon gv.There were 4 different cases reported having similar issues.There was no patient harm in all these cases and there were no products to be returned.This report is three out of five.Separate reports are being submitted capturing the other similar events.

• Brand Name: HEALON
• 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: 13779396
• MDR Text Key: 294602863
• Report Number: 3012236936-2022-00660
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Public: (01)(10)UNKNOWN
• 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: Physician
• Type of Report: Initial
• Report Date: 03/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HEALON GV
• Device Catalogue Number: 10294801
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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