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); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2025
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.The device is not an implantable device.Section d6b - explant date: not applicable.The device is not an implantable device; therefore, not explanted.Section e1 - telephone number: (b)(6).Device evaluation: a review of the records related to the device was performed.The system and its components met all specifications prior to being released.As a result of the investigation there is no indication of a product quality deficiency.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.Additionally, the probability of harm and severity as documented in this complaint are within defined ranges of the risk management file.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that suction loss occurred during flap treatment in the patient's left eye (os).Because of this, the treatment resulted in an incomplete flap.The docking did not appear to be well centered.No additional information was received.

• 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: 22070807
• Report Number: 3012236936-2025-000138
• Device Sequence Number: 18516830
• Product Code: GEX
• UDI-Device Identifier: 05050474738553
• UDI-Public: (01)05050474738553
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/22/2025

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: 04/30/2025
• Initial Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2023
• 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
• Patient Sex: Unknown