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	Keratitis (1944)
Date of Event	11/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a laser vision correction patient had surgery on (b)(6), 2023 and presented on (b)(6), 2023 with stage 3 diffuse lamellar keratitis (dlk) in both eyes.The topical steroid dosage was increased.It was stated that the patient had no loss of best corrected visual acuity (bcva).The patient had no complaints.It was reported that the event was not lasting and disabling, significantly interfering with daily activities.No additional information was provided.
Additional Manufacturer Narrative
Section a4 and a5: the customer does not collect this information therefore, not available.Section h3-other (81): a review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.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 ; 1700 e st andrew place; santa ana, CA 92705 ; 7142478552
• MDR Report Key: 18323214
• Report Number: 3012236936-2023-03175
• Device Sequence Number: 20603422
• Product Code: GEX
• UDI-Device Identifier: 05050474573468
• UDI-Public: (01)05050474573468
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/13/2023

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
• 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: Not provided
• Initial Report FDA Received Date: 12/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: WAVELIGHT SN: (B)(6).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 35 YR
• Patient Sex: Male