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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER PUREPOINT LASER; LASER, OPHTHALMIC
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ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER PUREPOINT LASER; LASER, OPHTHALMIC Back to Search Results
Catalog Number 8065750597
Device Problem Failure to Deliver Energy (1211)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/15/2023
Event Type  malfunction  
Event Description
A customer reported that an ophthalmic operating laser console would not emit the laser energy.The procedure and patient harm was not reported.
 
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).
 
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Brand Name
PUREPOINT LASER
Type of Device
LASER, OPHTHALMIC
Manufacturer (Section D)
ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER
15800 alton parkway
irvine CA 92618
Manufacturer (Section G)
ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER
15800 alton parkway
irvine CA 92618
Manufacturer Contact
jonathan schlech
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8007579780
MDR Report Key18226545
MDR Text Key329215578
Report Number2028159-2023-01610
Device Sequence Number1
Product Code HQF
UDI-Device Identifier00380657505975
UDI-Public00380657505975
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K062624
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 02/14/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/29/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number8065750597
Was Device Available for Evaluation? Yes
Date Manufacturer Received01/23/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/06/2009
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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