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U.S. Department of Health and Human Services

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

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ALCON LABORATORIES IRELAND LTD. CLAREON TORIC IOL LENS, INTRAOCULAR, TORIC OPTICS Back to Search Results
Model Number CNW0T5
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/22/2022
Event Type  malfunction  
Event Description
A physician reported after an iol was implanted, two line-like foreign materials were found on the back of the iol. When aspirated them by irrigation and aspiration (ia), one was removed, but the other was not. The surgery was completed without product replacement. The patient after surgery had no problems, including the va. Additional information has been requested and received which states the two line could also be referred to scratch.
 
Manufacturer Narrative
A sample device was not returned for analysis. Complaint history and product history records were reviewed and documentation indicated the product met release criteria. Root cause has not been identified. There have been no other complaints reported in the lot number. The manufacturer internal reference number is: (b)(4).
 
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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 Key14885131
MDR Text Key295904416
Report Number9612169-2022-00309
Device Sequence Number1
Product Code MJP
UDI-Device Identifier00380652410724
UDI-Public00380652410724
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 09/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/01/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCNW0T5
Device Lot Number21285353
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/01/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/01/2022 Patient Sequence Number: 1
Treatment
CLAREON MONARCH IV IOL, INJECTOR; HEALON; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D
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