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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON LENSX, INC. LENSX LASER SYSTEM; OPHTHALMIC FEMTOSECOND LASER
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ALCON LENSX, INC. LENSX LASER SYSTEM; OPHTHALMIC FEMTOSECOND LASER Back to Search Results
Model Number 550
Device Problem Material Integrity Problem (2978)
Patient Problem Edema (1820)
Event Date 11/13/2018
Event Type  malfunction  
Manufacturer Narrative
Investigation, including root cause analysis, is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.(b)(4).
 
Event Description
A customer reported an undercut flap in the central zone in the form of an oval one millimeter by three millimeters and two smaller islands located slightly below 12 o'clock in diameters of 1 millimeter each.After an unsuccessful attempt to raise the flap, the surgeon decided not to perform lasik.Additional information received states that the patient was seen in follow up and noted small edema but was assessed as satisfactory.The flap was laid and well adapted.The surgeon plans to perform a surgery on the left eye in one month.
 
Manufacturer Narrative
Based on assessment, the product met specifications at the time of release.The root cause of the reported event cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).
 
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Brand Name
LENSX LASER SYSTEM
Type of Device
OPHTHALMIC FEMTOSECOND LASER
Manufacturer (Section D)
ALCON LENSX, INC.
33 journey
suite #175
aliso viejo CA 92658
MDR Report Key8147605
MDR Text Key129888715
Report Number2028159-2018-02561
Device Sequence Number1
Product Code OOE
Combination Product (y/n)N
PMA/PMN Number
K163551
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 02/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number550
Device Catalogue Number8065998162
Was Device Available for Evaluation? No
Date Manufacturer Received01/29/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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