FDA Adverse Event Malfunction Summary report: N

S4-IR-CE

MDR report key: 8294158 · Received January 31, 2019

Report

Report Number: 3006695864-2019-00084
Event Type: Malfunction
Date Received: January 31, 2019
Date of Event: December 9, 2018
Report Date: November 6, 2020
Manufacturer: JOHNSON & JOHNSON SURGICAL VISION, INC.
Product Code: LZS
UDI-DI: 05050474573512
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IN
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

THIS CORRECTION MDR IS BEING SUBMITTED TO ADDRESS INACCURATE INFORMATION IN SECTION F ON THE XML VERSION OF THE PREVIOUS SUBMISSION CAUSED BY A SOFTWARE GLITCH IN THE TRANSMISSION PROCESS. THE INTERNAL NON-CONFORMANCE NUMBERS FOR THIS SOFTWARE ISSUE ARE NR-0148919 AND CAPA-010215.

Additional Manufacturer Narrative · 1

(B)(6). FIELD SERVICE SPECIALIST VISITED THE ACCOUNT AND FOUND RECALIBRATED IRIS MOTOR AND SLITWIDTH MOTOR AND CORRECT THE ISSUE. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

Additional Manufacturer Narrative · 1

CORRECTED DATA: IN THE INITIAL REPORT, THE MANUFACTURING DATE THAT WAS PROVIDED WAS INCORRECT; THE CORRECT DATE OF MANUFACTURE IS 8/24/2011. THE FOLLOWING FIELD HAS BEEN UPDATED ACCORDINGLY: DEVICE MANUFACTURE DATE: 8/24/2011, ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE TREATMENT STOPPED AT 70% AND THE SYSTEM GAVE A FLUENCE ERROR. THE TREATMENT WAS ABORTED ON THAT DAY AND WAS COMPLETED ON THE NEXT DAY AFTER MACHINE SERVICE WAS DONE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
85383	S4-IR-CE	EXCIMER LASER	LZS	JOHNSON & JOHNSON SURGICAL VISION, INC.	0030-4966		05050474573512

Patients

Seq	Age	Sex	Outcome	Treatment
1