MAUDE Adverse Event Report: AMO MANUFACTURING USA, LLC ELITA; POWERED LASER SURGICAL INSTRUMENT

Model Number	0155-1001
Medical Device Problem Codes	Decrease in Suction (1146); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a2, a4 and a5: per regulation eu 2016/679 (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Section d6a - implant date: not applicable.Elita is not an implantable device.Section d6b - explant date: not applicable.Elita is not an implantable device; therefore, not explanted.Section e1 - telephone number: (b)(6).Section h6 clinical code 4581: decentered flap.Section device code 3191: dissatisfaction.Device evaluation: a field service engineer (fse) visited site to check system and thought this was unlikely a technical issue and appeared to be an issue with docking technique with new surgeons.Fse confirmed cut position and vacuum levels.The system is performing to specification.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review and possible product return and evaluation, 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 on (b)(6) 2024, the physician performed his first elita flap procedure.After two unsuccessful attempts to dock the right eye (od), the surgeon decided to proceed with the left eye (os).The first attempt with the left eye successfully achieved applanation and complete docking.However, the flap size was reduced to 8.5 mm, but the surgeon chose to continue with the procedure.The patient¿s report image clearly indicated that prior to pressing the footswitch to engage the laser, both the eye and flap template were properly centered.However, immediately following the procedure, the image showed significant decentration of the eye, with the flap partially created on the cornea and partially on the sclera.After a 30-minute wait, he treated the patient with transprk, as the patient requested same-day treatment.The surgeon also requested that no further treatments be conducted until a thorough system check was completed to investigate the issue during the procedure.The patient¿s daily activities were not significantly affected.Through follow-up we learned that the surgeon expressed dissatisfaction with the lack of a warning about the vacuum loss and noted that the image on the screen was not live.Despite this, the surgeon reported that the patient was doing well, with no impairment or vision loss.The decision to perform prk on both eyes after 30 minutes was made to meet the patient¿s expectations.No additional information was provided.Note: a separated report will be sent for the patient interface.

• Brand Name: ELITA
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• 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: 21154547
• Report Number: 3012236936-2025-000009
• Device Sequence Number: 9097936
• Product Code: GEX
• UDI-Device Identifier: 05050474738553
• UDI-Public: (01)05050474738553
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• PMA/510(K) Number: K063682
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0155-1001
• Device Catalogue Number: 0155-1001
• 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: 12/19/2024
• Initial Report FDA Received Date: 01/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2024
• 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: PATIENT INTERFACE LN: 66967291.
• Patient Sex: Prefer Not To Disclose