FDA Adverse Event Malfunction Summary report: Y

CATALYS LASER

MDR report key: 17419075 · Received July 28, 2023

Report

Report Number: 3012236936-2023-01949
Event Type: Malfunction
Date Received: July 28, 2023
Report Date: October 30, 2023
Manufacturer: JOHNSON & JOHNSON SURGICAL VISION, INC.
Product Code: OOE
UDI-DI: 05050474609792
PMA / PMN Number: K113479
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER
Health Professional: N

Narratives

Additional Manufacturer Narrative · 0

ADDITIONAL INFORMATION: TWO INVESTIGATIONS WERE COMPLETED DURING THE REPORTING PERIOD. NO PRODUCT DEFICIENCY WAS IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

Additional Manufacturer Narrative · 0

SERIAL NUMBERS OF THE DEVICES AND QUANTITY: (B)(6) (1X), (B)(6) (1X), (B)(6) (1X), (B)(6) (2X), (B)(6) (4X), (B)(6) (3X), (B)(6) (1X), (B)(6) (2X), (B)(6) (1X), (B)(6) (2X), (B)(6) (8X). TWENTY-FOUR (24) INVESTIGATIONS WERE COMPLETED DURING THE PERIOD. A REVIEW OF THE RECORDS RELATED TO THE DEVICE THAT INCLUDED LABELING, MANUALS, TRENDING, AND RISK DOCUMENTATION WAS PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWED THAT THE SYSTEM AND ITS COMPONENTS MET ALL SPECIFICATIONS PRIOR TO BEING RELEASED. NO PRODUCT DEFICIENCY WAS IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

Description of Event or Problem · 0

THIS REPORT SUMMARIZES 26 MALFUNCTION EVENTS. THE EVENT WAS RELATED TO SUCTION LOSS DURING LASER FIRING. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1967945	CATALYS LASER	OPHTHALMIC FEMTOSECOND LASER	OOE	JOHNSON & JOHNSON SURGICAL VISION, INC.	CATALYS-U		05050474609792

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown