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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 Defective Device (2588)
Patient Problem Insufficient Information (4580)
Event Date 06/28/2022
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 manufacturer internal reference number is: (b)(4).
 
Event Description
A physician reported that after implantation of an intraocular lens (iol) the edge of iol was found to be deformed after implanting.Although he/she thought that it was damaged by the implanting process, it turned out that it was already deformed when taking it out of the case when checked through surgical video after the surgery.The surgery was completed without product replacement.The product was not replaced since it was a slight deformation and it was considered that there would be no damage to the patient's health.Additional information was requested.
 
Manufacturer Narrative
The video shows lens to be damaged as the lens is removed from the iol case.The root cause is potentially manufacturing related.If the iol becomes misaligned in the lens case, iol damage may occur.Based on the results from the product history record, the products met release criteria.Three photos provided.The optic edge appears to be chipped in the two photos taken during surgery, the reported complaint cannot be confirmed from the remaining the manufacturer internal reference number is: (b)(4).
 
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Brand Name
CLAREON TORIC IOL
Type of Device
LENS, 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 Key15081519
MDR Text Key298071612
Report Number9612169-2022-00348
Device Sequence Number1
Product Code MJP
UDI-Device Identifier00380652402385
UDI-Public00380652402385
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 Physician
Type of Report Initial,Followup
Report Date 11/19/2022
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
Device Operator Health Professional
Device Model NumberCNW0T5
Device Lot Number25322388
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/28/2022
Initial Date FDA Received07/22/2022
Supplement Dates Manufacturer Received10/26/2022
Supplement Dates FDA Received11/19/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/30/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
CLAREON MONARCH IV IOL INJECTOR; MONARCH III IOL CARTRIDGE D; PROVISC
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