MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON IOL; INTRAOCULAR LENS

Model Number	SY60WF
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that during a cataract extraction with intraocular lens (iol) implant procedure, the patient noted small defects on peripheral optic.The iol was remained implanted.Additional information has been requested and received stated that defect was noticed on the lens after injecting it into the eye.The harm to the patient is not visually significant.No further information available.
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON IOL
• 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: 16221252
• Report Number: 9612169-2023-00089
• Device Sequence Number: 12626375
• Product Code: HQL
• UDI-Device Identifier: 00380652251372
• UDI-Public: 00380652251372
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/21/2023

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: SY60WF
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/23/2022
• Initial Report FDA Received Date: 01/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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; UNSPECIFIED CARTRIDGE; UNSPECIFIED HANDPIECE
• Patient Sex: Unknown