MAUDE Adverse Event Report: AMO MANUFACTURING USA, LLC STAR S4 IR; EXCIMER LASER SYSTEM

Model Number 0030-2450

Device Problems Decrease in Suction (1146); Unintended System Motion (1430)

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

Event Date 04/07/2022

Event Type  malfunction  

Manufacturer Narrative

Field service engineer visited site to service the system and confirmed the reported issue of chair moving.Fse found that the joystick was broken and slowly driving the chair from right eye (od) to left eye (os) position.Fse replaced the joystick.System meets manufacturers specifications.A review of the records related to this equipment that included labeling, manual, and risk documentation reviews for this equipment was performed.Equipment labeling provides possible complications that can be caused by the surgical/treatment procedure being performed.The trend review shows that there is not a recognizable adverse trend.The risks and mitigation's associated with the complaint issue are identified in existing risk documents and no new risks were identified as part of this investigation.There was no product deficiency identified.All pertinent information available to johnson & johnson surgical vision has been submitted.

Event Description

It was that on (b)(6) 2022, the bed was drifting during the procedure of the right eye and it caused the patient interface (pi) to lose suction and didn't complete the flap.They tried a different pi and had the same issue, so they stopped attempting on this eye.The patient returned on (b)(6) 2022 and successfully completed the right eye.No additional information has been provided.

• Brand Name: STAR S4 IR
• Type of Device: EXCIMER LASER SYSTEM
• Manufacturer (Section D): AMO MANUFACTURING USA, LLC; 510 cottonwood drive; milpitas CA 95035
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 14311756
• MDR Text Key: 290962321
• Report Number: 3012236936-2022-01208
• Device Sequence Number: 1
• Product Code: LZS
• UDI-Device Identifier: 00(01)(21)5392
• UDI-Public: (01)(21)5392
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P930016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0030-2450
• Device Catalogue Number: 0030-2450
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2004
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: LOT# 60334442
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Ethnicity: Hispanic
• Patient Race: White