MAUDE Adverse Event Report: AMO MANUFACTURING USA, LLC INTRALASE FS LASER; POWERED LASER SURGICAL INSTRUMENT

Model Number 20005K

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

Patient Problems Corneal Clouding/Hazing (1878); Keratitis (1944); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/24/2020

Event Type  Injury  

Manufacturer Narrative

Sex/gender: unknown / not provided.(b)(6).Occupation: unknown / not provided.(b)(4).The system was evaluated by a field service engineer.The field service found no issues with the unit.A field service checklist was performed.The unit complied with all factory settings.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 the system and its components met all specifications prior to being released.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 with side cut haze, post surgery.Patient also had diffuse lamellar keratitis in the left eye (os) and a flap lift and wash was performed on (b)(6) 2020.Patient was also treated with femto + cross linking.No additional patient information has been provided.

• Brand Name: INTRALASE FS LASER
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): AMO MANUFACTURING USA, LLC; 510 cottonwood drive; milpitas CA 95035
• Manufacturer Contact: somyata nagpal ; 510 cottonwood drive; milpitas, CA 95035 ; 7142478552
• MDR Report Key: 11311721
• MDR Text Key: 231981669
• Report Number: 3006695864-2021-07158
• Device Sequence Number: 1
• Product Code: HNO
• UDI-Device Identifier: 05050474540231
• UDI-Public: (01)05050474540231
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K060372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 20005K
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2008
• 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: 26 YR