MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON CLAREON ASPHERIC HYDROPHOBIC ACRYLIC IOL; INTRAOCULAR LENS

Model Number SY60WF

Device Problems Defective Device (2588); Scratched Material (3020)

Patient Problem Corneal Edema (1791)

Event Date 08/15/2022

Event Type  malfunction  

Manufacturer Narrative

A sample device was not returned for analysis.Product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

An ophthalmic surgeon reported that during a cataract extraction with an intraocular lens (iol) implant procedure, the lens was loaded properly and inserted within 15 seconds after loading.The lens presented in the eye with a scratch.The surgeon said the haptic was nearly avulsed and that it never released from the haptic.Hence lens was removed from the patient's eye.Additional information was received stating patient experienced post operative edema.Then vision was normal a week later and edema resolved.Patient was not hospitalized as a result of this event.

Manufacturer Narrative

A photo was provided of the single-piece lens in the eye.One haptic tip is visible at the top of the photo on the anterior optic surface.The second haptic is folded in on the anterior optic surface.A long crack is observed, across the lower portion of the optic.The crack travels from the optic/haptic junction across to the opposite optic edge.The haptic is laying over the damaged area.Unable to determine, if the haptic is also cracked or if the crack is visible through the haptic.Qualified associated products were indicated.The root cause for the lens damage cannot be determined.Based on review of the provided photo, the reported damage appears to be a crack, not the reported scratch.The damage is across the optic, not in the fold/travel path.The position of the damage may indicate, a plunger over/underride occurred.No other determination can be made from the provided photo.Information was provided, that the lens was loaded properly and inserted within 15 seconds after loading.The surgeon said, the haptic was nearly avulsed and that it never released from the haptic.This may also indicate, a plunger override and/or a lack of viscoelastic.The instruction for use (ifu) instructs to completely fill the cartridge with ophthalmic viscosurgical devices (ovd) (diagram provided) immediately, prior to loading and delivery of the lens.Do not attempt to load the lens without adequate ophthalmic viscosurgical devices (ovd) in the device.Not adequately filling the device with viscoelastic will result in inadequate coverage of lens and the lens fold path with ophthalmic viscosurgical devices (ovd), which may result in damage.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON ASPHERIC HYDROPHOBIC ACRYLIC IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 15376924
• MDR Text Key: 305821839
• Report Number: 1119421-2022-01915
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P190018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/28/2022

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
• Device Operator: Health Professional
• Device Model Number: SY60WF
• Device Catalogue Number: SY60WF.140 CLAREON
• Device Lot Number: 15273834
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/18/2022
• Initial Date FDA Received: 09/08/2022
• Supplement Dates Manufacturer Received: 11/03/2022
• Supplement Dates FDA Received: 11/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CLAREON MONARCH IV IOL, INJECTOR; MONARCH III IOL, CARTRIDGE D; PROVISC
• Patient Sex: Male