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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER LENSX LASER SYSTEM; OPHTHALMIC FEMTOSECOND LASER
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ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER LENSX LASER SYSTEM; OPHTHALMIC FEMTOSECOND LASER Back to Search Results
Model Number 550
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Insufficient Information (4580)
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.The manufacturer internal reference number is: (b)(4).
 
Event Description
A facility representative reported a patient with unspecified sticky and incomplete flap during flap creation.Additional information has been requested.
 
Manufacturer Narrative
The system manufacturing device history record (dhr) was reviewed.Based on assessment, the product met specifications at the time of release.The company service representative examined the system and was unable to confirm or replicate any system nonconformity, which may have contributed to the reported event.The system was then tested and met all product specifications.The system was found to meet specifications; therefore, 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 RESEARCH, LLC - IRVINE TECHNOLOGY CENTER
15800 alton parkway
irvine CA 92618
MDR Report Key11148447
MDR Text Key227796723
Report Number2028159-2021-00043
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,other
Type of Report Initial,Followup
Report Date 04/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2021
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? Yes
Date Manufacturer Received03/23/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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