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

Model Number	590106AN
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/08/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a2, a4 and a5: per regulation eu 2016/679 (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Section d6a - implant date: not applicable to suspect device.Section d6b - explant date: not applicable to suspect device.Section e1 - telephone number: (b)(6).Section e1 - email address: unknown, as information was requested but not provided.Section h6 - health effect - clinical code: 4581: striae : corneal striae / flap dislocation/ dislodged : corneal flap complications.Section h3 - the device was not returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.Manufacturing records review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.Attempts have been made to obtain missing information.However, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that after the patient was treated with the ifs femtosecond laser on (b)(6) 2026, the patient experienced striae in the right eye (od).The patient had to return for flap lift, wash and rinse on the (b)(6) 2026.No further information was provided.Pachymetry: od/left eye (os) = 548/544.Preop best corrected visual acuity (bcva) od = 6/5.Preop bcva os = 6/5.Preop refraction od = s -6.5 c-0.75 a 155/.Preop refraction os = s -6.5 c-0.75 a 155/s-6.25 c-0.50 a 20.1 day postop uncorrected visual acuity (ucva) od = 6/20.1 day postop ucva os = 6/7.5.1 post flap lift ucva od = 6/6.1 post flap lift ucva os = 6/5.Note: this report is against the patient interface.A separate report is being filed against the ifs femtosecond laser.

• Brand Name: FS DISPOSABLE INTERFACE
• Common Device Name: 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: 25332247
• Report Number: 3012236936-2026-000125
• Device Sequence Number: 9881225
• Product Code: GEX
• UDI-Device Identifier: 15050474534688
• UDI-Public: (01)15050474534688(17)271021(10)60688749
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K060372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/29/2026

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: 590106AN
• Device Catalogue Number: 590106AN
• Device Lot Number: 60688749
• 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: 05/01/2026
• Initial Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/21/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LASER SN: (B)(6).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown