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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample device was not returned for analysis.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).
Event or Problem Description
A registered nurse reported following an intraocular lens (iol) implant procedure, the patient complained of blind spot in center of vision beginning one week post operation for each eye.The lens was explanted and replaced with company lens in a secondary procedure.Additional information was requested, but further no information was available.There are two medical device reports associated with this patient.This report is associated with the right eye.
Event or Problem Description
Additional information was received stating in the surgeon¿s opinion, hyperopic surprise- possible elp was more posterior.Her vision was blurry.Patient's symptoms were resolved.There was no patient harm and patient was not hospitalized as a result of this event.
Additional Manufacturer Narrative
Correction information was provided in b.5, b.6, d.10, e.4, and h.6.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The product was returned for analysis.Iol returned in 3 segments in a plastic container.A significant amount of solution is dried on the segments.No further testing can be performed due to severe optic damage.Hcp reported that the event was due to "hyperopic surprise- possible elp was more posterior".The root cause for the reported complaint could not be determined.According to the information in the file the event was due to "hyperopic surprise- possible elp was more posterior".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: 16113926
• Report Number: 9612169-2023-00027
• Device Sequence Number: 17556458
• Product Code: HQL
• UDI-Device Identifier: 00380652397360
• UDI-Public: 00380652397360
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/11/2026
• Device Model Number: CCA0T0
• Device Lot Number: 25469446
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/14/2022
• Supplement Date Received by Manufacturer: 01/16/2023; 03/31/2023
• Initial Report FDA Received Date: 01/06/2023
• Supplement Report FDA Received Date: 02/13/2023; 04/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PROVISC
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female