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

Model Number 0030-4864

Device Problem Unintended System Motion (1430)

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

Event Date 06/13/2023

Event Type  malfunction  

Manufacturer Narrative

Device evaluation: the investigation by the field service engineer resulted in no problems found.The system meets specifications and no product deficiency is present.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.

Event Description

Customer reported that their star laser chair moved without any input.The chair was locked and doctor was ready to treat.He pressed the foot pedal after the machine verified iris registration, and it would act like it was going to fire, but it would stop treatment due to losing focus/tracking because the patient was moving down from the desired spot.

Manufacturer Narrative

Section h4.Device manufacture date corrected to dec 29, 2006.Additional information: manufacturing record review was performed.There were no discrepancies or non-conformances experienced during manufacturing.The system and its components met all specifications prior to being released.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.

• 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 ; 1700 e st andrew place; santa ana, CA 92705 ; 7142478552
• MDR Report Key: 17313272
• MDR Text Key: 319279934
• Report Number: 3012236936-2023-01752
• Device Sequence Number: 1
• Product Code: LZS
• UDI-Device Identifier: 05050474573413
• UDI-Public: (01)05050474573413
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P910062
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 08/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0030-4864
• Device Catalogue Number: 0030-4864
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/13/2023
• Initial Date FDA Received: 07/12/2023
• Supplement Dates Manufacturer Received: 07/26/2023
• Supplement Dates FDA Received: 08/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/29/2006
• 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