MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF ASPHERIC UV ABSORBING SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number	SA60WF
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample device was not returned for analysis.Complaint history and product history records were reviewed, and documentation indicated the product met release criteria.Root cause has not been identified.There has been two other complaint reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A nurse reported that during a cataract extraction with intraocular lens (iol) implant procedure, a very clear mark or scratch was observed in the middle of the lens after the iol was delivered in the bag.The lens has been cut for removal from the patient¿s eye.The replacement lens was used and the surgery was completed.There was patient contact with the product but no patient harm was reported.The patient's symptoms were resolved.Additional information has been requested.
Additional Manufacturer Narrative
The lens was returned in the lens case.Viscoelastic was dried on the lens.Both haptics were folded in on the anterior optic surface.One haptic was broken gusset area.This damage appeared to have been caused by the return placement in the lens case.The lens was cleaned with klrp.A scratch is observed, off center on the anterior optic surface.This was a small narrow scratch, similar in appearance to damage caused by in instrument used to grasp the lens.A qualified cartridge and handpiece were indicated.The viscoelastic used was not provided.It is unknown, if a qualified product was used.A small narrow scratch was observed, on the anterior surface of the optic.This scratch is similar in appearance to damage, that can be caused by in instrument used to grasp the lens (loading forceps).All lenses are 100% inspected for cosmetic attributes.The observed, scratch would not have met company release criteria.Based on our observation, and the review of manufacturing records, it can be reasonably concluded, that the damage is not manufacturing related.Due to the presence of surgical solution and the condition of the returned sample, the damage is most likely related to customer handling.Information was provided by the facility, that they think the damage was from the forceps, or the plunger.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF ASPHERIC UV ABSORBING SINGLEPIECE IOL
• Common Device Name: 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: 14877608
• Report Number: 1119421-2022-01434
• Device Sequence Number: 5145657
• Product Code: HQL
• UDI-Device Identifier: 00380652332729
• UDI-Public: 00380652332729
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2022

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: 02/07/2026
• Device Model Number: SA60WF
• Device Catalogue Number: SA60WF.230
• Device Lot Number: 15145529
• 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: 06/03/2022
• Supplement Date Received by Manufacturer: 10/04/2022
• Initial Report FDA Received Date: 06/30/2022
• Supplement Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2021
• 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 CARTRIDGE D; MONARCH III INJECTOR; UNSPECIFIED FORCEPS; UNSPECIFIED VISCOELASTIC
• Patient Sex: Unknown