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

Model Number 0030-4864

Device Problem Failure to Sense (1559)

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

Event Date 05/27/2021

Event Type  Injury  

Manufacturer Narrative

Weight and ethnicity: unknown, not provided.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.

Event Description

It was reported that the excimer laser would not capture iris registration (ir) and that the eye image looked out of focus.The patient flaps were already created and the procedure had to be rescheduled.On (b)(6) 2021 it was confirmed that the patient came back for secondary surgical procedure.The treatment was completed successfully.Patient is doing well.No loss of best corrected visual acuity (bcva).

Manufacturer Narrative

Correction: in review, of medwatch 3006695864-2021-07951.This event has been assessed not reportable due the fact, the procedure was aborted prior to the flap lift and prior to laser firing, the surgeon made the decision not to lift the flap preventing flap damage, hence, this is not considered required intervention to prevent permanent impairment or damage: medical or surgical intervention is necessary to preclude permanent impairment of body function, or prevent permanent damage to a body structure was the result of the event.There will be no more information provided for mfg reporting no.3006695864-2021-07951.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
• MDR Report Key: 12032284
• MDR Text Key: 257216341
• Report Number: 3006695864-2021-07951
• Device Sequence Number: 1
• Product Code: LZS
• UDI-Device Identifier: 05050474573413
• UDI-Public: (01)05050474573413
• Combination Product (y/n): N
• PMA/PMN Number: P910062
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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
• Date Manufacturer Received: 06/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention