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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON - IRVINE TECHNOLOGY CTR ILLUMINATED FLEX CURVED LASER BROBE, 23GA; LASER, OPHTHALMIC
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ALCON - IRVINE TECHNOLOGY CTR ILLUMINATED FLEX CURVED LASER BROBE, 23GA; LASER, OPHTHALMIC Back to Search Results
Model Number 8065751592
Device Problem Sparking (2595)
Patient Problem No Patient Involvement (2645)
Event Date 05/20/2014
Event Type  malfunction  
Event Description
A surgeon reported experiencing a faulty sparking laser probe before surgery.There was no patient involvement.Additional information has been requested.
 
Manufacturer Narrative
A sample has been received and in-house testing is in progress.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).
 
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Brand Name
ILLUMINATED FLEX CURVED LASER BROBE, 23GA
Type of Device
LASER, OPHTHALMIC
Manufacturer (Section D)
ALCON - IRVINE TECHNOLOGY CTR
15800 alton pkwy.
irvine CA 92618
Manufacturer (Section G)
ALCON - IRVINE TECHNOLOGY CTR
15800 alton pkwy.
irvine CA 92618
Manufacturer Contact
janet moran
6201 south freeway, r3-48
fort worth, TX 76134
8176152742
MDR Report Key3964721
MDR Text Key21311403
Report Number2028159-2014-01148
Device Sequence Number1
Product Code HQF
Combination Product (y/n)N
Reporter Country CodeSF
PMA/PMN Number
K062624
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 05/21/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/19/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/30/2015
Device Model Number8065751592
Device Catalogue Number8065751592
Device Lot Number13029118X
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer05/30/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/21/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/01/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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