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

Model Number	G300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Sensation in Eye (1869); Headache (1880); Blurred Vision (2137); Visual Impairment (2138)
Date of Event	05/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A manufacturer record review related to the device including device history record will be performed.Upon completion of this review, if there is any further relevant information obtained that changes the facts and/or conclusion, a supplemental medwatch will be filed.Manufacturing date not available at the time of this report all pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that patient had lasik cutomvue myopic treatment on (b)(6) 2021.Presented 1 day post op with foreign body sensation and at one week post reported having pressure sensation like a slight headache with blurry vision.At the 1 month post op visit patient reported vision not good in right eye and best corrected visual acuity (bcva) was 20/50.Tearing reported.Patient had a lid scrub performed.At 2 month post-op on (b)(6) 2021 patient had re-treatment of right eye.Right eye -1.75 x 0.75 x 165 bcva 20/50 (prior to re-treatment) right eye repeat -1.50 x 0.50 x 169 bcva 20/40 +2.Patient reported that right not good for distance, have tearing and is bloodshot experience foreign body sensation.Patient claims that when taking showers eye gets foggy and last 1/2 hour and still experiencing some double vision.9 week post-op on (b)(6) 2021 (3 month post-op) right eye (od) -1.00 x 0.75 x 138 sands corrected visual acuity 20/50 bcva 20/20.Patient reports new pain, tearing, no visual improvement.
Additional Manufacturer Narrative
Correction for device evaluation: it was inadvertently not included in the initial report that the device was evaluated by a field service engineer (fse) who went onsite and checked calibration on the idesign which passed.The fse also discussed the idesign calculations with the account.Section d9 device available for evaluation? yes.H3 device evaluated by manufacturer? yes.H6 code for type of investigation10 - testing of actual/suspected device.Additional information: h4 manufacturing date was not provided in the initial report.The manufacturing date is 10/29/2015.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• 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 ; 1700 e st andrew place; santa ana, CA 92705 ; 7142478552
• MDR Report Key: 12734436
• Report Number: 2020664-2021-07988
• Device Sequence Number: 11991989
• Product Code: LZS
• UDI-Device Identifier: 05050474591912
• UDI-Public: (01)05050474591912
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 12/01/2021

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: G300
• 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: 10/05/2021
• Supplement Date Received by Manufacturer: 11/04/2021
• Initial Report FDA Received Date: 11/02/2021
• Supplement Report FDA Received Date: 12/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2015
• 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: STAR S4 IR SN (B)(6) ; STAR S4 IR SN (B)(4).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female