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

Model Number	J20007D
Medical Device Problem Codes	Mechanical Problem (1384); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a2 a3, a4 and a5: unknown/ not provided section b3 date of event: unknown/not provided section d6a: if implanted, give date: not applicable, as the device is not implantable.Section d6b: if explanted, give date: not applicable, as the device is not implantable.Section h6 health effect - clinical code: thin flap and micro striae device evaluation: field service engineer (fse) visited site to evaluate reported issue and could not reproduce but verified 211 errors in error log.Proactively performed z-scale test and all ok.Proactively cleaned dust from top of objective.No other observations have been made.System conforms to all j&j specifications.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 and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that patient had thin flap and micro striae.At one day post patient had flap relifted and smoothed out.Patient is in good condition with normal healing.It was also reported that system was getting galvo error 211 and video communication issues error 601.No additional information was provided.

• 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 ; 510 cottonwood drive; milpitas, CA 95035 ; 7142478552
• MDR Report Key: 22020381
• Report Number: 3012236936-2025-000138
• Device Sequence Number: 9504475
• Product Code: GEX
• UDI-Device Identifier: 05050474573468
• UDI-Public: (01)05050474573468
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/14/2025

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: J20007D
• Device Catalogue Number: J20007D
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2025
• Initial Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2020
• 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 Sex: Unknown