MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. IFS; FEMTOSECOND LASER

Model Number J20007D

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Inflammation (1932)

Event Date 11/25/2020

Event Type  Injury  

Manufacturer Narrative

A record review was performed.A product deficiency review was performed and there is no product deficiency identified.A document, service history, and trending was reviewed.There is not a recognizable adverse trend.The risks and mitigations associated with the complaint issue are identified in existing risk documents and no new risks were identified as part of this investigation.A labeling review was conducted; the operator manual for the system was reviewed and found to include adequate instructions for use, warnings and operational errors.The review of the device history record (dhr) for femtosecond laser system showed that there were no issues or non-conformities.The system and its components met all specifications prior to being released.Manufacturing has been ruled out as a potential cause for the reported issue.Based on the investigation results, no corrective action has been issued.Based on the investigation results there is no indication of a product quality deficiency.Johnson & johnson surgical vision will continue to monitor this type of complaints.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.

Event Description

It was reported that a laser vision correction patient had surgery on (b)(6) 2020 and presented on (b)(6) 2020 with inflammation in both eyes (ou), post treatment.Medrol dose pack, an oral steroid was prescribed and the topical steroid dosage was increased.A flap lift and rinse was also performed.It was stated that the patient had no loss of best corrected visual acuity (bcva).The patient had no complaints.Patient reported symptoms are not interfering with daily activities.

• Brand Name: IFS
• Type of Device: FEMTOSECOND LASER
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• Manufacturer (Section G): JOHNSON & JOHNSON SURGICAL VISION, INC.; 510 cottonwood drive; milpitas CA 95035
• Manufacturer Contact: somyata nagpal ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478200
• MDR Report Key: 11039606
• MDR Text Key: 222647014
• Report Number: 3006695864-2020-00555
• Device Sequence Number: 1
• Product Code: HNO
• UDI-Device Identifier: 05050474573468
• UDI-Public: (01)05050474573468
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K060372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: J20007D
• Device Catalogue Number: J20007D
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/26/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR