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

Model Number	0030-4864
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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).
Additional 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
• Common Device Name: EXCIMER LASER SYSTEM
• Manufacturer (Section D): AMO MANUFACTURING USA, LLC; 510 cottonwood drive; milpitas CA 95035
• MDR Report Key: 12032284
• Report Number: 3006695864-2021-07951
• Device Sequence Number: 17368167
• Product Code: LZS
• UDI-Device Identifier: 05050474573413
• UDI-Public: (01)05050474573413
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P910062
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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 Received by Manufacturer: 05/27/2021
• Supplement Date Received by Manufacturer: 06/21/2021
• Initial Report FDA Received Date: 06/21/2021
• Supplement Report FDA Received Date: 06/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention