MAUDE Adverse Event Report: AMO MANUFACTURING USA, LLC FS DISPOSABLE INTERFACE; POWERED LASER SURGICAL INSTRUMENT

Model Number	590106AN
Medical Device Problem Code	Decrease in Suction (1146)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient interface (pi) suction ring may lose suction during a procedure.Label copy states corneal fixation vacuum loss can occur.There are several factors that may contribute to suction issues such as doctor¿s technique in applying the suction ring to the cornea, doctor¿s technique in squeezing the pi clip to secure the suction ring to the pi cone and patient anatomy affecting the interface between the patient¿s cornea and the suction ring.A review of records related to the device including labeling, complaint trending, and risk documentation will be performed.Upon completion of this review, if there is any further relevant information obtained, a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
The account reported suction loss after the laser fired occurred with a patient interface.The surgery was completed successfully by switching to photorefractive keratectomy (prk).No additional information was received.
Additional Manufacturer Narrative
Section a2, a3, a4, a5 patient demographics provided: white, male, date of birth: 5/25/1969, age at time of event.52, gender.Male, race.Caucasian , ethnicity.Non- (hispanic/latino or non-hispanic/latino) section d9 device available for evaluation "yes" returned on oct 6, 2022 section h2 additional information/device evaluation section h6 testing of actual suspect device: device evaluation: 1 opened pi received within original packaging confirming the reported lot number.A visual inspection of the returned product did not reveal any obvious defects or damage.Functional testing was performed with all results within specifications.The reported issue could not be confirmed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Correction: section b - outcomes attributed to adverse event.The checkmark for "required intervention to prevent permanent impairment/damage (devices)" no longer applies.H6 health effect - impact code 4625 no longer applies.Photorefractive keratectomy (prk) code was removed as prk is not considered surgical intervention to treat a complication or is required to preclude permanent damage or injury.Prk is an alternative means of correcting visual acuity.Based on the information above this event is a reportable malfunction and not a serious adverse event and will be submitted under vmsr program.

• Brand Name: FS DISPOSABLE INTERFACE
• 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: 15654977
• Report Number: 3012236936-2022-02663
• Device Sequence Number: 2428504
• Product Code: GEX
• UDI-Device Identifier: 05050474535305
• UDI-Public: (01)05050474535305(17)231029(10)60335190
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K060372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/13/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/29/2023
• Device Model Number: 590106AN
• Device Catalogue Number: 590106AN
• Device Lot Number: 60335190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 09/23/2022
• Supplement Date Received by Manufacturer: 11/10/2022; 12/15/2022
• Initial Report FDA Received Date: 10/21/2022
• Supplement Report FDA Received Date: 12/09/2022; 01/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2021
• 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: LASER S/N (B)(6).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White