MAUDE Adverse Event Report: AMO MANUFACTURING USA, LLC IDESIGN ADVANCED WAVESCAN STUDIO; EXCIMER LASER SYSTEM

Model Number	0110-2261
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Weight and ethnicity has been requested but not available at the time of this report.Date of event: unknown/not provided a review of the records related to the device that included labeling, manuals, trending, and risk documentation reviews was performed.A review of the device history record (dhr) showed that the system and its components met all specifications prior to being released.The trend review shows that there is not significant change over historical complaint limits and no 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 has been submitted.
Event or Problem Description
Account reported patient had photorefractive keratectomy treatment and presented hyperopic post treatment.Patient initial visit refraction: right eye +1.50-0.75x144 20/20.Left eye +1.75 sph 20/20.Cyclopegic refraction: right eye +1.75-0.75x141.Left eye +1.75 sph.Prk treatment: right eye +1.46-0.79x130 20 microns.Left eye +3.75 (goal of -2.00 for near) 36 microns.3 months post op refraction: right eye +1.25--0.75x135 20/20.Left eye -0.50-0.25x136 20/20.5 months post op refraction: right eye +0.25-1.00x180 20/20.Left eye -0.25-0.25x155 20/30.

• Brand Name: IDESIGN ADVANCED WAVESCAN STUDIO
• Common Device Name: EXCIMER LASER SYSTEM
• Manufacturer (Section D): AMO MANUFACTURING USA, LLC; 510 cottonwood drive; milpitas CA 95035
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 14215331
• Report Number: 3012236936-2022-01116
• Device Sequence Number: 20144492
• Product Code: LZS
• UDI-Device Identifier: 05050474591912
• UDI-Public: (01)05050474591912
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P930016
• 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 Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/26/2022

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: 0110-2261
• Device Catalogue Number: 0110-2261
• Was Device Available for Evaluation?: Yes
• 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: 03/30/2022
• Initial Report FDA Received Date: 04/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2016
• 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 Age: 49 YR
• Patient Sex: Female