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

Model Number	SA60AT
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2021
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 have been no other complaints reported in the lot number.  additional information has been requested.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A nurse reported that during an intraocular lens (iol) implant procedure, after the iol was implanted into the patient's eye, the doctor noticed a marking on the lens.The surgeon was unsure if it was a scratch mark or a forceps mark.The iol was removed and replaced with a new lens to complete the procedure.The patient is doing well.
Additional Manufacturer Narrative
Product evaluation: the lens was returned placed under the sheet of adhesive surgical product.The assembled lens case was also returned in the opened carton.Viscoelastic was dried on the lens.The optic has been cut into two pieces, typical in appearance to damage created when removing a lens from the eye.The optic edge was split and a scrape mark travelled onto the anterior optic surface.The optic portions have areas that are cracked.Product history records were reviewed and documentation indicated the product met release criteria.The customer indicated the use of a qualified cartridge, handpiece, and viscoelastic.The forceps used to load the lens into the cartridge were unspecified.Root cause: the reported lens damage was observed.The optic has been cut into two pieces, typical in appearance to damage created when removing a lens from the eye.All lenses are 100% inspected for cosmetic attributes and the damage exhibited by the returned complaint sample would not have met manufacturers 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 in the file that the surgeon is unsure if it is a scratch mark or a forceps mark.Surgeon decided to explant the lens and implant a new lens.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Qualified associated products were indicated.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF SINGLEPIECE IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 11785729
• Report Number: 1119421-2021-00968
• Device Sequence Number: 14498283
• Product Code: HQL
• UDI-Device Identifier: 00380652555753
• UDI-Public: 00380652555753
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/13/2021

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: 11/30/2023
• Device Model Number: SA60AT
• Device Catalogue Number: SA60AT.175
• Device Lot Number: 12673697
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2021
• Initial Date Received by Manufacturer: 04/18/2021
• Supplement Date Received by Manufacturer: 05/10/2021; 08/25/2021
• Initial Report FDA Received Date: 05/06/2021
• Supplement Report FDA Received Date: 05/12/2021; 09/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MONARCH CARTRIDGE C; MONARCH III INJECTOR; UNK FORCEPS; VISCOAT OVD