MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON ASPHERIC UV ABSORBING IOL WITH AUTONOME DELIVERY SYSTEM; INTRAOCULAR LENS

Model Number	CCA0T0
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	Visual Disturbances (2140)
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that following an intraocular lens (iol) implant procedure, refractive surprise post operatively, lens could have been labeled wrong.Additional information has been requested and received from physician stating the patient was doing well with a six correction logic (scl) correction.He had most experienced cornea/refractive review the case and he was confident future ptk left eye (os) upon the patient's return late spring will result in a satisfactory outcome.The chances of a mislabeled iol in manufacturing process was extremely low.Most likely the issue was the very different k topos between her od (excellent expected result) and os (refractive surprise).The topo os certainly has a pellucid marginal degeneration appearance which we all know can have wildly unpredictable refractive results given the high rate of k sloping close to the visual axis.
Additional 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.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The reporter stated: "the chances of a mislabeled iol in manufacturing process is extremely low.Most likely the issue is the very different k topos between her od (excellent expected result) and os (refractive surprise).The topo os certainly has a pellucid marginal degeneration appearance which we all know can have wildly unpredictable refractive results given the high rate of k sloping close to the visual axis." photographs 1 and 2 do not identify which eye each corresponds to.Photograph 2 exhibits steepening of the inferior cornea, which is not present in photograph 1.The topography image in photograph 2 represents findings that may contribute to the reported event.Based on the two images i reviewed, there is not enough information to determine whether the reported event was or was not related to a manufacturing deficiency.No root cause can be identified with the available information.The product was not returned for evaluation.A definitive determination cannot be made without the evaluation of the physical product.The reporter stated: "the chances of a mislabeled iol in manufacturing process is extremely low.Most likely the issue is the very different k topos between her od (excellent expected result) and os (refractive surprise).The topo os certainly has a pellucid marginal degeneration appearance which we all know can have wildly unpredictable refractive results given the high rate of k sloping close to the visual axis." the manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON ASPHERIC UV ABSORBING IOL WITH AUTONOME DELIVERY SYSTEM
• Common Device Name: INTRAOCULAR LENS
• 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 Key: 18204705
• Report Number: 9612169-2023-00831
• Device Sequence Number: 12598939
• Product Code: HQL
• UDI-Device Identifier: 00380652397315
• UDI-Public: 00380652397315
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2024

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
• Operator of Device: Health Professional
• Device Model Number: CCA0T0
• Device Lot Number: 25630117
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/01/2023
• Supplement Date Received by Manufacturer: 01/24/2024
• Initial Report FDA Received Date: 11/24/2023
• Supplement Report FDA Received Date: 02/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Female