• 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
Lot Number ASKU
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/02/2022
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 non-healthcare professional reported that during an intraocular lens (iol) implant procedure, a plastic slivers stuck to the lens after implantation through a cartridge. There were no patient complications resulting from this foreign body material. The plastic slivers were removed. There are five medical device reports associated with this event. This is 1 of 5. 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 Key14564783
MDR Text Key293080603
Report Number9612169-2022-00243
Device Sequence Number1
Product Code MJP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P190018
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 08/25/2022
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received06/01/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot NumberASKU
Was Device Available for Evaluation? No
Date Manufacturer Received07/29/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/01/2022 Patient Sequence Number: 1
Treatment
MONARCH III CARTRIDGE D
-
-