MAUDE Adverse Event Report: AMO MANUFACTURING USA, LLC IDESIGN RS; EXCIMER LASER SYSTEM

Model Number	G301
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	12/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation: an application support manager (asm) visited site and provided surgery support.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 and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that patient had surgery on (b)(6) 2022 and was overcorrected in the left eye.Idesign manifest refraction (mr) -9.12 +2.90 x 100, mr.-8.25 +2.75 97 best corrected visual acuity (bcva) 20/20.An enhancement was performed on (b)(6)2022.Idesign mr -.10 +1.14 x79, mr +1.25 sph.Physician adj +.50.Patient ended up with 20/25 uncorrected visual acuity (ucva).No refraction has been done and patient is not due to return for another 6 months.No additional information was provided.This report is for the idesign.A separate report will be filed for the excimer laser.

• Brand Name: IDESIGN RS
• 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: 16710855
• Report Number: 3012236936-2023-00881
• Device Sequence Number: 1609899
• Product Code: LZS
• UDI-Device Identifier: 05050474651432
• UDI-Public: (01)05050474651432
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 04/10/2023

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: G301
• Device Catalogue Number: 0110-3450
• 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: 03/15/2023
• Initial Report FDA Received Date: 04/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2021
• 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: EXCIMER LASER SN (B)(6).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 44 YR
• Patient Sex: Female