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

Model Number VT585U

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Eye Burn (2523)

Event Date 01/10/2023

Event Type  Injury  

Event Description

It was reported that a patient had a wound burn of the unknown eye.There was a plume at the phaco tip when surgeon went into ultrasound in sculpt indicating it wasn¿t clearing.At that point it was switched to epinucleus to clear the endocoat, which is suspected was blocking the flow, and the plume cleared.However, the thermal damage at the wound had already been done.It was surmised the issue was the endocoat as it hadn¿t fully cleared form the tip and working space before surgeon began his groove.Surgeon closed the wound with a 10-0 nylon stitch and felt he had good closure.The case was prolonged by a few minutes for the stitch and to check wound integrity.It was later reported that at 1 day post-op there was barely any thermal damage on the affected eye.The suture was removed a week later and the patient is doing great.No additional information was provided.This report is for the healon endocoat.Reference mrn 3012236936-2023-00236 for the phaco handpiece, 3012236936-2023-00235 for the veritas console and 3012236936-2023-00237 for the phaco tip.

Manufacturer Narrative

A review of records related to the device including labeling, complaint trending, and risk documentation will be performed.Upon completion of this review, if there is any further relevant information obtained, a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: UNK_OVD_HEALON ENDOCOAT
• 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: 16307578
• MDR Text Key: 308888918
• Report Number: 3012236936-2023-00238
• Device Sequence Number: 1
• Product Code: LZP
• 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: 02/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VT585U
• Device Catalogue Number: UNK-OVD_HEALON ENDOCOAT
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/10/2023
• 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
• Treatment: VERITAS CONSOLE, HANDPIECE, OPOCR3021R
• Patient Outcome(s): Required Intervention
• Patient Sex: Female