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	09/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient had surgery on september 8, 2022 and was overcorrected on both eyes.Right eye (od) - idesign manifest refraction (mr) -2.96 +0.52 x 29, mr -2.91 +.25 x 10 20/20 best corrected visual acuity (bcva).Left eye (os) - idesign mr -2.93 +0.18 x 172, mr -3.16 sph.20/20 bcva.Enhancement done on december 22, 2022 for left eye only.Idesign mr +2.54 +1.45 x 0, mr +1.84 +1.00 x 10.Physician adj -0.50.As of (b)(6) 2023 the patient was seeing 20/30 uncorrected visual acuity (ucva), they have not done an mr on the patient.While the od was not enhanced, the current mr is +1.25 +.50 x15 with 20/20 bcva.However, the patient wears a contact lens (cl) and only sees 20/30 with the cl.Patient declined an enhancement on the od.The patient does appear to have a good bit of higher order aberrations (hoas) in both eyes.The idesign se for the os was -2.84 and the eff blur was 4.14 d.Pre-op k¿s for the os were 45.30/46.57 x168 and after the enhancement were measuring 39.30/41.90 x175.No additional information was provided.This report is for the idesign.A separate report will be filed for the excimer laser.
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.

• 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: 16710650
• Report Number: 3012236936-2023-00892
• Device Sequence Number: 16556431
• 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: 04/10/2023
• 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 3669
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 21 YR
• Patient Sex: Female