MAUDE Adverse Event Report: AMO MANUFACTURING USA, LLC UNK_PATIENT INTERFACE; KERATOME, AC-POWERED

Model Number UNK-PATIENT INTERFACE

Device Problem Decrease in Suction (1146)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/21/2024

Event Type  malfunction  

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 d4 - model #: a complete model # is unknown, as product lot number was not provided.Section d4 - catalogue#: a complete catalogue # is unknown, as product lot number was not provided.Section d4 - lot#: unknown/ not provided section d4 - expiration date: unknown as product lot number was not provided.Section d4 - udi #: unknown as product lot number was not provided.Section d6a - implant date: not applicable.The patient interface is not an implantable device.Section d6b - explant date: not applicable.The patient interface is not an implantable device; therefore, not explanted.Section e1 - telephone number: (b)(6).Section h3 - other (81): the patient interface was not returned for evaluation.Therefore, a failure analysis of the complaint device could not be completed.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.Section h4 - device manufacture date: unknown as product lot number was not provided.Attempts have been made to obtain missing information.However, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that during the flap lift on the patient eye, the physician realized that around 180° of the side cut was not completed.The physician used scissors to cut the tissue and treated the patient.The patient is fine with 0.9 va and the patient's eye was treated and everything was perfectly fine.The physician believes there this was caused by a vacuum loss, however there was no warning and nothing was looking wrong on the machine.The issue was noticed during the flap procedure.Through follow-up we confirmed that the issue was a suction loss but he did not observe anything wrong during the procedure.He noticed the issue during flap lift attempt and no further information was provided.

• Brand Name: UNK_PATIENT INTERFACE
• Type of Device: KERATOME, AC-POWERED
• 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: 18987760
• MDR Text Key: 338760117
• Report Number: 3012236936-2024-00963
• Device Sequence Number: 1
• Product Code: HNO
• UDI-Public: (01)
• Combination Product (y/n): N
• Reporter Country Code: LO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK-PATIENT INTERFACE
• Device Catalogue Number: UNK-PATIENT INTERFACE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: LASER SN: (B)(6).
• Patient Sex: Female