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

Model Number	20005D
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Keratitis (1944)
Date of Event	01/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient from case day on (b)(6) 2025 presented with diffuse lamellar keratitis (dlk) both eyes (ou) on day 1 post op.Patient vision was 20/200 ou.Surgeon started patient with steroid drop every 2 hours for 24 hours and then started on oral steroid for a 14 day taper dose.Surgeon saw patient on (b)(6) 2025 and left eye (os) inflammation appeared to resolve but right eye (od) still presented with mild inflammation and was continuing with steroid drops every 4 hours.On (b)(6) 2025 visit os vision was 20/20 and od was 20/40.Surgeon will see patient in two weeks and will provide update if further treatment is needed.Laser energy settings were discussed with surgeon and surgeon stated that she doesn't feel it is laser involvement but feels that it is patient specific as he had other health related issues around the same time, he had the lasik procedure.Additional information received: pre lasik-visual acuity (va): sans corrected; od 20/350, os 20/300, ou 20/300, with correction dvo¿s; od 20/20 os 20/20-1 ou 20/20.Post lasik va 1 day; od 20/60, os 20/25-1, ou 20/20, 2 day; od 20/250, os 20/25+2, started on oral pred, 3 day; od 20/60-2, os 20/20, 5 day; od 20/25-1, os 20/25-1, 8 day; od 20/60, od 20/25, ou 20/30+3, 12 day; od 20/50, os 20/25, ou 20/30, tapering oral pred, 19 day; od 20/50, os 20/25-2, ou 20/20-2, 1 month; od 20/50, os 20/70, ou 20/30, recurrence of defect, restart oral pred, 1 month 1 day; od 20/40+1, os 20/40+1.
Additional Manufacturer Narrative
Device evaluation: sales rep discussed laser energy settings with surgeon who reported that event was not laser related.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Correction: section h6 type of investigation: in the initial report code was submitted as #10 however, the correct code is #4114.Additional information: manufacturing records review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.Conclusion: as a result of the investigation there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: FS LASER SYSTEM
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): AMO MANUFACTURING USA, LLC; 510 cottonwood drive; milpitas CA 95035
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 21565568
• Report Number: 3012236936-2025-000069
• Device Sequence Number: 9170578
• Product Code: GEX
• UDI-Device Identifier: 05050474573451
• UDI-Public: (01)05050474573451
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K063682
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 20005D
• Device Catalogue Number: 20005D
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2025
• Supplement Date Received by Manufacturer: 04/11/2025
• Initial Report FDA Received Date: 03/10/2025
• Supplement Report FDA Received Date: 04/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2010
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR
• Patient Sex: Male