FDA Adverse Event Injury Summary report: N

CATALYS SYSTEM

MDR report key: 7889844 · Received September 19, 2018

Report

Report Number: 3005675890-2018-00077
Event Type: Injury
Date Received: September 19, 2018
Report Date: November 3, 2020
Manufacturer: JOHNSON & JOHNSON SURGICAL VISION, INC
Product Code: OOE
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

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). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT; LASER CORRECTION SYSTEM, MODEL CATALYS-I, THAT HAS A SIMILAR PRODUCT, CATALYS-U WHICH IS DISTRIBUTED IN THE UNITED STATES UNDER 510(K) # K121091. 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.

Description of Event or Problem · 1

IT WAS REPORTED THAT A CAPSULE TEAR OCCURRED DURING CAPSULOTOMY. A 3 PIECE SINGLE FOCAL INTRAOCULAR LENS WAS IMPLANTED. THE OUTCOME OF THE PATIENT IS UNKNOWN. ATTEMPTS TO GET ADDITIONAL INFORMATION HAD BEEN DONE HOWEVER, AT THE TIME OF THIS REPORT NO INFORMATION HAS BEEN PROVIDED. THIS IS REPORT IS FOR UNIDENTIFIED PATIENT 2 OF 3.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
731286	CATALYS SYSTEM	CATALYS	OOE	JOHNSON & JOHNSON SURGICAL VISION, INC	CATALYS-I

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other