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

Model Number SY60WF

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem Blurred Vision (2137)

Event Type  malfunction  

Event Description

A physician reported that following a cataract extraction with an intraocular lens (iol) implant procedure, postoperative pigment was adhered behind intraocular lens (between the intraocular lens and the posterior capsule) immediately after surgery in a case after implanting the lens.This case occurred while irrigation and aspiration were carefully performed.The sample was not available as it still remains in the patient's eye.Additional information was received stating patient experienced blurred vision and iridopsia.Patient's symptoms were improving.There are two medical device reports associated with this complaint.This report is 2 of 2.

Manufacturer Narrative

The product was not returned for analysis; the lens remains implanted.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).

Manufacturer Narrative

Additional information was provided in h.3, h.6 and h.10.The root cause for the reported complaint could not be determined as no sample was returned for analysis.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 IOL
• Type of Device: 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: 16003957
• MDR Text Key: 308389689
• Report Number: 9612169-2022-00698
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P190018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SY60WF
• Device Lot Number: 25246231
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MONARCH III IOL, INJECTOR
• Patient Age: 76 YR
• Patient Sex: Female