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)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that following treatment with the ifs femtosecond laser between (b)(6) 2025, six patients experienced striae flap displacement in unknown eye.The patients had to return for flap lift, wash and rinse.No further information was provided.Through follow-up, additional information was obtained; however, it is unclear to which of the patients this information pertains.Therefore, this information is being included in all corresponding complaint files.One (1) patient has left eye (os) best corrected visual acuity (bcva) preop 6/6 and 6/7 post flap lift.The rest have achieved uncorrected visual acuity (ucva) post flap lift 6/6 or above.One with ucva 6/7.5 and bcva of 6/6.No one lost more than 2 lines of bcva.Note: this report pertains to the patient interface for one of the six patients.A separate report is being submitted for the associated ifs femtosecond laser.Additionally, separate reports are being submitted for the patient interface for the remaining five patients, as well as the ifs femtosecond laser.
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 b3 - date of event: date unknown, as information was requested but not provided section d4: lot number: unknown/not provided.Section d4: expiration date: unknown, as the lot number of the device was not provided.Section d4: udi #: a complete udi # is unknown as product lot number was not provided.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.A review of records including device history and complaint trending will be performed.Upon completion of this review, if there is any further relevant information a supplemental medwatch will be filed.Section h4: device manufacture date: unknown, as the lot number of the device was not provided.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.

• 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: 25324246
• Report Number: 3012236936-2026-000148
• Device Sequence Number: 21316813
• Product Code: GEX
• UDI-Device Identifier: 15050474534688
• UDI-Public: (01)15050474534688(10)UNKNOWN
• 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): 05/28/2026

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: UNKNOWN
• Was Device Available for Evaluation?: No
• 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: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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