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 Blurred Vision (2137); Discomfort (2330); No Code Available (3191)

Event Date 08/03/2020

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 folded flap on the right eye (od), discovered on slit lamp exam post treatment.The patient's chief complaint was of blurry vision and discomfort.It was stated that the patient had no loss of best corrected visual acuity (bcva).Patient flap lifted, smoothed, and repositioned.Patient was seen on (b)(6) 20020 for a post op.Vas were right eye (od) 20/20, left eye (os) 20/20, both eyes (ou) 20/15.Bcva from (b)(6) 2020.Right eye pre-op 20/20 -2.25 x.00 x 90.Left eye pre-op 20/20 -2.25 x.00 x 90.Bcva from (b)(6) 2020.Right eye post-op 20/20.Left eye post-op 20/20.Both eyes (ou) 20/15.

Manufacturer Narrative

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 (b)(4) and capa-010215.

• 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: 10484080
• MDR Text Key: 205472065
• Report Number: 3006695864-2020-00414
• 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: 01/01/2005,10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• 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
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 10/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: WAVELIGHT SERIAL NUMBER (B)(4)
• Patient Outcome(s): Required Intervention
• Patient Age: 23 YR