MAUDE Adverse Event Report: IDESIGN RS; EXCIMER LASER SYSTEM

Model Number	0110-3450
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
(date of birth) ,weight, ethnicity unknown/not provided.Date of event: unknown/not provided.An application support manager (asm) reviewed the images by logging in virtually to the idesign to review the exams and treatment plans with the account and nothing out of the ordinary noted.Captures looked good and very little difference seen between the manifest at optical infinity and the idesign manifest at optical infinity.A review of the records related to this equipment that included labeling, manual, and risk documentation reviews for this equipment was performed.Equipment labeling provides possible complications that can be caused by the surgical/treatment procedure being performed.The trend review shows that there is not a 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 surgical vision has been submitted.
Event or Problem Description
It was reported that a laser vision correction patient was treated september 2020 with idesign and photorefractive keratectomy (prk) that was overcorrected.Original rx was -1.25 +0.75 and the patient ended up being +.25 +.75.Patient was retreated in may 2021.No loss of best corrected visual acuity (bcva) reported.Patient is doing well.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
• MDR Report Key: 12544794
• Report Number: 2020664-2021-07580
• Device Sequence Number: 4031968
• Product Code: LZS
• UDI-Device Identifier: 05050474651432
• UDI-Public: (01)05050474651432
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K000327
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/28/2021

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: 0110-3450
• Device Catalogue Number: 0110-3450
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2021
• Initial Report FDA Received Date: 09/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2019
• 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)(4)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR