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

Model Number	590106AN
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Appropriate Device Problem Term/Code Not Available (3191); Noise, Audible (3273)
Health Effect - Clinical Code	Corneal Abrasion (1789)
Date of Event	04/11/2026
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 h6 - health effect - impact code 4650: bandage contact lens.Section h6 - device code 3191: dissatisfaction.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 when using the patient interface (pi) there were issues with suction rings.They were very stiff, creaky and difficult to use, which affected the meniscus and epithelium (slip) and caused abrasions in bilateral eyes which required the application of bcl.The procedure was completed.No further information was provided.This report is 2 of 2 reported.

• 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: 25178858
• Report Number: 3012236936-2026-000108
• Device Sequence Number: 21517814
• Product Code: GEX
• UDI-Device Identifier: 15050474534688
• UDI-Public: (01)15050474534688(17)271020(10)60688080
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/14/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 590106AN
• Device Catalogue Number: 590106AN
• Device Lot Number: 60688080
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/20/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown