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	Material Discolored (1170)
Health Effect - Clinical Code	Blurred Vision (2137)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A nurse reported that following an intra-ocular lens (iol) implant procedure, patient had clear vision initially day 1 (20/30) but then a decline in acuity to 20/50 by week 2.Optical coherence tomography (oct) was normal and no improvement with refraction.When they dilated her at week 2 there was a hazy crystalline sheen within the central lens material inferiorly and extending into the central axis.The lens was explanted in a secondary procedure.
Additional Manufacturer Narrative
Product manufacturing site updated due to receipt of receipt of product serial number.Manufacturer report number corrected and reported under [9612169-2024-00287].The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The product was returned for analysis and the reported complaint "hazy crystalline sheen in the central lens" was not observed.Only iol in segments received in a specimen container.Solution is dried on both surfaces of the optic and haptics.Iol split/cut in 4 pieces and scratched/marked-rejectable, no observations.Iol(intraocular lens) cleaned for further evaluation.No observations of the reported "hazy crystalline sheen".The reported complaint was observed post implantation.The file states that "defect was not present on initial implantation".No root cause identified as the reported complaint "failure, hazy crystalline sheen in the central lens" was not observed on the returned product.We are unable to confirm the presence of the reported "hazy crystalline sheen in the central lens" after iol implantation.The lens was returned in several segments, the observed damage is consistent with lens having been explanted.The reported complaint was observed post implantation.The file states that "defect was not present on initial implantation".Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received stating lens was replaced with other company lens.

• 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 WV 00000 ; EI 00000
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork WV 00000 ; EI 00000
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 18551062
• Report Number: 1119421-2024-00127
• Device Sequence Number: 12727378
• Product Code: HQL
• UDI-Device Identifier: 00380652397360
• UDI-Public: 00380652397360
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/12/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: CCA0T0
• Device Lot Number: 25660039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/27/2023
• Supplement Date Received by Manufacturer: 03/05/2024; 06/14/2024
• Initial Report FDA Received Date: 01/22/2024
• Supplement Report FDA Received Date: 04/03/2024; 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female