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U.S. Department of Health and Human Services

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

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ALCON LABORATORIES IRELAND LTD. CLAREON PANOPTIX TORIC TRIFOCAL HYDROPHOBIC IOL LENS, INTRAOCULAR, TORIC OPTICS Back to Search Results
Model Number CNWTT4
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem Insufficient Information (4580)
Event Date 05/10/2022
Event Type  malfunction  
Manufacturer Narrative
The product was returned for analysis. 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. Results from the product history record review indicated the product met release criteria. There have been no other complaints reported in the lot number. The manufacturer internal reference number is: (b)(4).
 
Event Description
A healthcare professional reported that during implantation of an intraocular lens (iol) the mark which seemed to be either a white glue-like foreign material or a damage was found on the haptic after implanting. It was not able to be removed although removal through irrigation and aspiration was attempted. The surgery was completed by explanting the iol and implanting the backup lens. Additional information was requested.
 
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Brand NameCLAREON PANOPTIX TORIC TRIFOCAL HYDROPHOBIC 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 Key14572800
MDR Text Key293158188
Report Number9612169-2022-00246
Device Sequence Number1
Product Code MJP
UDI-Device Identifier00380652468831
UDI-Public00380652468831
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
1 Patient was Involved in the Event
Date FDA Received06/02/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCNWTT4
Device Catalogue NumberCNWTT4.085
Device Lot Number25271356
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/27/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/15/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/13/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/02/2022 Patient Sequence Number: 1
Treatment
CLAREON MONARCH IV IOL INJECTOR; MONARCH III IOL CARTRIDGE D; OPEGAN-HI
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