MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. STAR S4 IR; EXCIMER LASER SYSTEM

Model Number	0030-4864
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Troubleshooting was done over the phone the day of the event and the technician reported to jnj that only a boost was done in the morning.Johnson and johnson technical support recommended performing a refill and a lens calibration again.Field service engineer (fse) visited the account a day after the event.Fse was told that they did a refill as well as a myopic lens calibration and fluency set and had no issues completing multiple surgeries afterward the day of the event.The patient that had 25 seconds remaining on the right eye and 3 seconds remaining on the left eye before they had to boost the gases again.Customer reports he was the highest hyperope they've treated.The laser alerted customer it could resume the patient treatment.System is operational and service was not required.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 while laser was firing the treatment stop due to fluence error.This occurred on the patient first eye (right).Surgeon decided not to complete the remaining 25 seconds and is waiting to re-refract the patient in a post op visit to decide if anymore laser treatment is needed.

• Brand Name: STAR S4 IR
• Common Device Name: EXCIMER LASER SYSTEM
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 11601718
• Report Number: 2020664-2021-07018
• Device Sequence Number: 19718887
• Product Code: LZS
• UDI-Device Identifier: 05050474573413
• UDI-Public: (01)05050474573413
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/01/2021

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
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2021
• Initial Report FDA Received Date: 04/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1