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

Model Number	SY60WF
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
An ophthalmologist reported that, following an intraocular lens (iol) implant procedure, optic of the iol found to be scratched.The surgery was performed and completed after replacing the product with another one.Additional information was received that, after insertion of the iol, a vertical white opacity was observed on the posterior surface of the iol.The iol was removed in three sections and a spare iol was inserted with the same injector and a different cartridge.The patient's postoperative course was good.
Additional Manufacturer Narrative
The product was returned for analysis.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 product was returned for analysis and the reported damage was observed.Iol returned adhered to gauze in three pieces, in non-company sealed pouch.Solution is dried on both surfaces of the optic and haptics.Both haptics have gauze fiber adhered.The optic is cut in 3 (three) and scratched/marked-rejectable with adhered gauze fiber.The root cause for the reported complaint "scratch on optic" could not be determined.The returned iol shows evidence of possible handling by the customer due to the presence of solution dried on both surfaces of the optic and haptics.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 iol contributed to the event.The product history records confirm that the product met release criteria.There have been no other complaints for this lot.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: 14485657
• Report Number: 9612169-2022-00235
• Device Sequence Number: 20164182
• Product Code: HQL
• UDI-Device Identifier: 00380652251426
• UDI-Public: 00380652251426
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2022

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 Expiration Date: 02/29/2024
• Device Model Number: SY60WF
• Device Lot Number: 21286171
• 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: 04/27/2022
• Supplement Date Received by Manufacturer: 07/22/2022
• Initial Report FDA Received Date: 05/24/2022
• Supplement Report FDA Received Date: 08/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2020
• 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: MONARCH III IOL CARTRIDGE D; MONARCH IV IOL INJECTOR
• Patient Age: 67 YR
• Patient Sex: Unknown