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	Dry Eye(s) (1814); Blurred Vision (2137); Visual Impairment (2138)
Date of Event	04/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient had lasik procedure performed on (b)(6) 2023 and presented at one day post op reporting that everything was blurry and there was a little dryness.Patient was given a sample of refresh drops and was to continue with current medications.On (b)(6) 2023 patient was seen for blurry vision in both eyes.The timing is described as sudden onset and quality is improving a little.Patient feels like he has slept in contacts.Recommended readers +1.50 and lasik enhancement.Relift enhancement both eyes was performed on (b)(6) 2023 and patient to continue with medication.On (b)(6) 2023, 6 months post-op patient describes it takes few minutes in the morning to adjust and reading is blurry.Relief is experienced from readers.No additional information was provided.
Additional Manufacturer Narrative
Manufacturing records review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.Conclusion: as a result of the investigation there is no indication of a product quality deficiency.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 ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 19515702
• Report Number: 3012236936-2024-000164
• Device Sequence Number: 6031177
• Product Code: LZS
• UDI-Device Identifier: 05050474591912
• UDI-Public: (01)05050474591912
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/11/2024

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?: No
• 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: 05/17/2024
• Initial Report FDA Received Date: 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2016
• 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: Required Intervention
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White