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 Codes	Eye Injury (1845); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer reported significant vertical gas breakthrough with a thinner flap (95 microns) flap with pocket turned off; it happened in multiple areas during the last 1/2 of the cut, no suction loss, surgery was aborted.Doctor states patient is doing ok and is fully recovered.Patient was not prescribed medication (outside of standard of care).Best corrected visual acuity (bscva) pre-operative: 20/20.Best corrected visual acuity (bscva) post-operative: 20/20.
Additional Manufacturer Narrative
Section a2, a3a, a3b, a4, a5 and a6: unknown, information was requested but not provided.Section e1 telephone number, (b)(6).Section h3: our field service engineer (fse) was onsite for a system evaluation.Flap thickness confirmed to be within specifications.Flap quality repair complete.Preventive maintenance complete.No other issue or complaint observations have been made.System conforms to all j&j specifications.A review of records including device history and complaint trending will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.
Additional Manufacturer Narrative
Corrected data: upon further review it was determined that section h4 device manufacture date in the initial mdr reported, the incorrect date was inadvertently provided.The correct date is 08/09/1999.Therefore, this supplemental report is being submitted to provide the correct data.Additional information: product evaluation was performed for this incident.No malfunction was determined, the device did not function as intended but only required minor adjustments or calibrations.User settings required calibration.Our field service engineer aligned amplifiers.Assessments of manufacturing, service, design, and usage were completed, and the system is performing to specification after the amplifiers were aligned.Reviews of labeling and risk management files were conducted, and no new issues/risks were identified.Johnson & johnson surgical vision will continue to monitor these types of complaints.The reported issue is an anticipated/expected event for the system and does not represent a new risk.Based on the last annual risk management review and ongoing post-market surveillance activities, the probability of occurrence for the reported event remains within the rates established in the product risk management files.A product deficiency has not been identified; therefore, no additional corrective actions have been initiated.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 ; 510 cottonwood drive; milpitas, CA 95035 ; 7142478552
• MDR Report Key: 23661450
• Report Number: 3012236936-2025-000313
• Device Sequence Number: 10375157
• Product Code: GEX
• UDI-Device Identifier: 05050474573468
• UDI-Public: (01)05050474573468
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2026

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: J20007D
• Device Catalogue Number: J20007D
• 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: 10/31/2025
• Supplement Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 01/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/1999
• 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