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	Corneal Clouding/Hazing (1878)
Date of Event	05/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer reported that a patient presented with mild central corneal haze after lasik treatment.The haze resolved with the normal post operative steroid use.Physician has had multiple lasik cases without corneal haze.Physician plans to review the site¿s instrument preparation/sterilization process.Per follow-up, physician cannot remember the patients.There were only 2, and i have not seen anyone else since then.Patient was given prednisolone acetate - the normal drop for post op, but physician increased the frequency to 6x/day instead of 4x/day to hopefully help with the haze.This report is for patient 2 of 2.
Additional Manufacturer Narrative
Section h3-other (81): the intralase femtosecond system was not evaluated; therefore, a failure analysis of the complaint device cannot be completed.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.H3 other text : see h10.
Additional Manufacturer Narrative
H10, corrected data: h4 ¿ manufacturing date ¿ the manufacturing site reported that the manufacturing date for the device is 05/20/2020.H10, additional information: h6 type of investigation codes 3331, 4110 and 4109.H6 investigation findings ¿ code 213.Device evaluation: a review of the records related to this equipment that included labeling, manual, trending, and risk documentation reviews for this equipment were performed.Equipment labeling provides possible complications that can be caused by the surgical/treatment procedure being performed.The trend review shows that there is not a recognizable adverse trend.The risks and mitigations associated with the complaint issue are identified in existing risk documents and no new risks were identified as part of this investigation.There was no product deficiency identified.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: 17146385
• Report Number: 3012236936-2023-01523
• Device Sequence Number: 5771958
• Product Code: GEX
• UDI-Device Identifier: 05050474573468
• UDI-Public: (01)05050474573468
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 06/27/2023

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
• 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: 05/19/2023
• Supplement Date Received by Manufacturer: 06/23/2023
• Initial Report FDA Received Date: 06/16/2023
• Supplement Report FDA Received Date: 06/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2020
• 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