Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER LEGION ANTERIOR VITRECTOMY HANDPIECE; UNIT, PHACOFRAGMENTATION
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER LEGION ANTERIOR VITRECTOMY HANDPIECE; UNIT, PHACOFRAGMENTATION Back to Search Results
Catalog Number 8065753050
Medical Device Problem Code Failure to Cut (2587)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 06/13/2026
Type of Reportable Event Malfunction
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
LEGION ANTERIOR VITRECTOMY HANDPIECE
Common Device Name
UNIT, PHACOFRAGMENTATION
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 Key25760160
Report Number2028159-2026-01003
Device Sequence Number9740781
Product Code HQC
UDI-Device Identifier00380657530502
UDI-Public(01)00380657530502(17)360221(11)260223(10)17Y809
Combination Product (Y/N)N
Initial Reporter CountryIN
PMA/510(K) Number
K191650
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source Foreign,Health Professional,Company Representative
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 07/09/2026
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
Operator of Device Health Professional
Device Catalogue Number8065753050
Device Lot Number17Y809
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/16/2026
Initial Report FDA Received Date07/09/2026
Date Device Manufactured02/23/2026
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Reuse
Patient Sequence Number1
Patient SexUnknown
-
-