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 Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A non-healthcare professional reported that when the intraocular lens (iol) was being implanted, there was a scratch noticed on the iol.According to the additional information received, the lens was removed and replaced with a new lens in an initial procedure.There was no patient harm.Surgery was performed on left eye.
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).
Additional Manufacturer Narrative
The iol was returned for analysis and the reported complaint was observed.No device was returned.Blister tray, p&l and carton and iol in sample container returned.The iol is cut in half, the observed damage is consistent with the lens having been explanted.There are stutter scratches on the optic.We are unable to determine the root cause for the reported complaint "scratch on the lens (in and out)".Only the iol was returned for analysis.The device was not returned.As a result, we are unable to conduct a comprehensive investigation to determine the root cause of the reported complaint.In addition to this, all iols are 100% cosmetically inspected as per approved manufacturing procedures and the observed lens damage would not meet our current release criteria.Based on these investigation findings, we are unable to verify if the product contributed to the event.Based on the results from the product history record, the products met release criteria.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: 20265875
• Report Number: 9612169-2024-00916
• Device Sequence Number: 15666230
• Product Code: HQL
• UDI-Device Identifier: 00380652397254
• UDI-Public: (01)00380652397254(17)271101(11)231103(10)25741869(21)25741869012
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2024

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: 25741869
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/22/2024
• Supplement Date Received by Manufacturer: 11/11/2024
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Patient Age: 70 YR
• Patient Sex: Unknown