MAUDE Adverse Event Report: AMO MANUFACTURING USA, LLC INTRALASE TECHNOLOGY PI; POWERED LASER SURGICAL INSTRUMENT

Model Number	0155-1825
Medical Device Problem Code	Decrease in Suction (1146)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2024
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.Patient interface is not an implantable device.Section d6b - explant date: not applicable.Patient interface is not an implantable device; therefore, not explanted.Section e1 - telephone number: (b)(6).Section h3: 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.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that on the left eye and on the second attempt doctor obtained enough meniscus and continued with flap creation.After laser was completed, on elita screen customer recognized that there was a suction loss.Meniscus was way smaller and flap bed was completed.Suction loss happened most probably during side cut.Doctor tried to open the side cut close to hinge but did not proceed since he clearly saw it was incomplete.The doctor decided to apply contact lens and wait till patient recovers and plan the surgery on another date.He will check the patient refraction to be stable, do anterior oct to check the flap before proceeding with the next treatment.Patient daily activities are not significantly affected.No further information was provided.

• Brand Name: INTRALASE TECHNOLOGY PI
• 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: 20042625
• Report Number: 3012236936-2024-000230
• Device Sequence Number: 20807236
• Product Code: GEX
• UDI-Device Identifier: 05050474655690
• UDI-Public: (01)05050474655690(17)241129(10)66967287
• Combination Product (Y/N): N
• Initial Reporter Country: AE
• PMA/510(K) Number: K060372
• 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): 08/22/2024

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 Expiration Date: 11/29/2024
• Device Model Number: 0155-1825
• Device Catalogue Number: 0155-1825
• Device Lot Number: 66967287
• 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: 07/30/2024
• Initial Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/29/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 0730-11070
• Patient Sex: Prefer Not To Disclose