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

Model Number	G301
Medical Device Problem Code	Environmental Compatibility Problem (2929)
Health Effect - Clinical Codes	Visual Impairment (2138); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a4 and a5: unknown/ not provided.An application support manager (asm) was at site and spoke on the importance of having an operating room environment that is stable/monitored and within recommended temperature and humidity ranges (68*f - 72*f / 40% - 45%); having the star and idesign regularly maintained by service engineers; patient manifest and cycloplegic refraction and corneal topography performed; a good tear film with dry eye condition resolved and under control.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a patient had customvue myopic lasik on (b)(6) 2024 on both eyes (ou) and was overcorrected.On (b)(6) 2024 patient had a conventional retreatment ou.Right eye is fine but left eye had epi ingrowth.It was also reported that patient has a history of dry eyes.During the time of surgery customer was also having heating, ventilation, and air conditioning (hvac) and operating room temperature was generally kept below the recommended range but has now been repaired.No additional information was provided.This report is against the idesign.A separate report will be filed against the star laser.
Additional Manufacturer Narrative
Additional information: account reported that patient's initial are cb and they do not wish to disclose weight and race.Product evaluation was performed for the incident.No malfunctions were found during evaluation.The probably cause was environmental issue and not equipment related.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 RS
• 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: 20466092
• Report Number: 3012236936-2024-000279
• Device Sequence Number: 7630001
• Product Code: LZS
• UDI-Device Identifier: 05050474651432
• UDI-Public: (01)05050474651432
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2024

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: 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: 09/19/2024
• Supplement Date Received by Manufacturer: 10/21/2024
• Initial Report FDA Received Date: 10/16/2024
• Supplement Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2022
• 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 SN (B)(6).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 46 YR
• Patient Sex: Male