• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON TORIC IOL LENS, INTRAOCULAR, TORIC OPTICS

  • 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 LABORATORIES IRELAND LTD. CLAREON TORIC IOL LENS, INTRAOCULAR, TORIC OPTICS Back to Search Results
Model Number CNW0T4
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem Insufficient Information (4580)
Event Date 08/09/2022
Event Type  malfunction  
Manufacturer Narrative
A sample device was not returned for analysis. The product history record could not be reviewed because facility did not provide a lot number or any identification traceable to the manufacturing documentation. Root cause has not been identified. The complainant indicates the use of non company viscoelastic, which is not qualified for use with company lens model, this is not a qualified company product combination. The manufacturer internal reference number is: (b)(4).
 
Event Description
A physician reported that following implantation of an intraocular lens (iol) the that a foreign material of about 3mm was found adhered to the rear surface of the iol after implanting. The foreign material was not there when it was set up. It may be deposits from the injector. The foreign material was removed by forceps and the surgery was completed without product replacement. Additional information was requested.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCLAREON TORIC IOL
Type of DeviceLENS, INTRAOCULAR, TORIC OPTICS
Manufacturer (Section D)
ALCON LABORATORIES IRELAND LTD.
cork business&technology park
model farm road
cork 00000
EI 00000
Manufacturer (Section G)
ALCON LABORATORIES IRELAND LTD.
cork business&technology park
model farm road
cork 00000
EI 00000
Manufacturer Contact
jonathan schlech
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8007579780
MDR Report Key15321343
MDR Text Key303410724
Report Number9612169-2022-00434
Device Sequence Number1
Product Code MJP
UDI-Device Identifier00380652410069
UDI-Public00380652410069
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P190018
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/07/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/30/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCNW0T4
Device Lot Number21285286
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/15/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-