MAUDE Adverse Event Report: AMO MANUFACTURING USA, LLC FS LASER SYSTEM; POWERED LASER SURGICAL INSTRUMENT

Model Number	20005D
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dry Eye(s) (1814); Blurred Vision (2137); Visual Impairment (2138); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Health effect: clinical code (b)(4): no code available (striae).An application support manager (asm) visited the site and optimized settings and provided surgery support.A review of the records related to this equipment that included labeling, manual, and risk documentation reviews for this equipment was 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 mitigation's 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 has been submitted.
Event or Problem Description
It was reported that patient had bilateral lasik procedure and presented at 1 day post-op with spectacle corrected visual acuity (scva) of 20/20 with mild ghosting on right eye (od) which was attributed to dry eye and 20/50 left eye (os) since surgery.Left eye mrx: -0.50 + 1.25 x 050, 20/20 with blurry vision.Patient stated vision is like looking through a cloud or tissue paper os.There were trace, peripheral microfolds which was smoothed at the slit lamp with no interface debris or diffuse lamellar keratitis (dlk).

• Brand Name: FS LASER SYSTEM
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): AMO MANUFACTURING USA, LLC; 510 cottonwood drive; milpitas CA 95035
• MDR Report Key: 11942483
• Report Number: 3006695864-2021-07866
• Device Sequence Number: 19890271
• Product Code: GEX
• UDI-Device Identifier: 05050474573451
• UDI-Public: (01)05050474573451
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K063682
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/04/2021

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: 20005D
• Device Catalogue Number: 20005D
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 06/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention