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 Problems Foreign Body Sensation in Eye (1869); No Code Available (3191)

Event Date 11/19/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 striae in right eye.Flap lift and rinse was performed.It was stated that the patient had no loss of best corrected visual acuity (bcva).The patient complained of foreign body sensation and light sensitivity.Patient reported symptoms are not interfering with daily activities.Bcva from (b)(6) 2015.Right eye pre-op 20/20 -3.75 x -.25 x 107, left eye pre-op 20/20 -3.50 x.00 x 90.

Manufacturer Narrative

It was initially reported that the pre-op bcva date was (b)(6) 2015 however, the correct date is (b)(6) 2020.

• 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
• MDR Report Key: 11041604
• MDR Text Key: 222646261
• Report Number: 3006695864-2020-00558
• Device Sequence Number: 1
• Product Code: HNO
• UDI-Device Identifier: 05050474573468
• UDI-Public: (01)05050474573468
• Combination Product (y/n): Y
• PMA/PMN Number: K060372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 12/21/2020

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
• Date Manufacturer Received: 12/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: WAVELIGHT (B)(6)
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR