MAUDE Adverse Event Report: AMO MANUFACTURING USA, LLC IFS ADVANCED FEMTOSEC LASER; POWERED LASER SURGICAL INSTRUMENT

Model Number	J20007D
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Eye Injury (1845)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient had presented post op with vertical gas breakthrough (vgb).No additional information was provided.
Additional Manufacturer Narrative
Device evaluation: field service was dispatched to perform system evaluation and replaced pre expander, performed auto correlation, spot size camera, alignments, gel evaluation and perform preventative maintenance.System performing to specification.On june 6, 2024, jnj clinical application specialist visited site and gelled laser at at 5/5 @ 0.65 with 80% melt, 6/6 @ 0.85 at 80% melt and 7/7 @ 1.05 at 80% melt.Doctor's settings are 7/7 with bed energy at 1.0 and side cut energy at 0.90.His flap thickness is set at 100um.Max energy at startup was 2.19uj.After gelling, clinical did an energy wheel initialization and it was 2.26uj.Room temperature was found at 65 degree f, humidity 33%.On june 7, 2024, clinical returned to site and observed 13 lasik cases performed by the doctor.Intralase performed well.Initial max energy 2.19 and subsequently stayed at 2.26 the rest of the day.Temp/humidity stayed constant at 65f/33%.Settings used were 1.00 bed energy, 0.90 side-cut energy, flap thickness 100um.Easy lifts and doctor was happy with its' performance.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: IFS ADVANCED FEMTOSEC LASER
• 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: 20286702
• Report Number: 3012236936-2024-000260
• Device Sequence Number: 15294603
• Product Code: GEX
• UDI-Device Identifier: 05050474573468
• UDI-Public: (01)05050474573468
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K141852
• 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
• Report Date (Section B): 09/23/2024

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: J20007D
• Device Catalogue Number: J20007D
• 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: 05/29/2024
• Initial Report FDA Received Date: 09/23/2024
• Date Device Manufactured: 08/12/2019
• 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: Other
• Patient Sex: Unknown