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U.S. Department of Health and Human Services

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

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AMO MANUFACTURING USA, LLC FS DISPOSABLE INTERFACE; POWERED LASER SURGICAL INSTRUMENT Back to Search Results
Model Number UNKNOWN
Device Problem Decrease in Suction (1146)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/18/2021
Event Type  malfunction  
Manufacturer Narrative
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.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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
 
Event Description
It was reported by the customer that they experienced suction loss with the patient interface during the laser firing.Procedure was completed successfully.There was no patient injury or surgical intervention needed.
 
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Brand Name
FS DISPOSABLE INTERFACE
Type of Device
POWERED LASER SURGICAL INSTRUMENT
Manufacturer (Section D)
AMO MANUFACTURING USA, LLC
510 cottonwood drive
milpitas CA 95035
MDR Report Key12189641
MDR Text Key262248791
Report Number3006695864-2021-08059
Device Sequence Number1
Product Code HNO
UDI-Public(01)(10)UNKNOWN
Combination Product (y/n)N
PMA/PMN Number
K060372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial
Report Date 07/19/2021
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
Device Operator Health Professional
Device Model NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/28/2021
Initial Date FDA Received07/19/2021
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 Number1
Treatment
LASER SN: (B)(4).
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