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	Insufficient Information (4580)
Date of Event	02/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was returned.Solution is dried on the lens.Haptic and optic damage was observed.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Associated products were not provided.It is unknown if qualified products were used.The reported damage was observed.All lenses are 100% inspected for cosmetic attributes and the damage exhibited by the returned complaint sample would not have met 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.There are no other complaints in this lot.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A facility representative reported that during a cataract surgery with an intraocular lens (iol) implantation, the iol was scratched.There was patient contact.The procedure was completed.Additional information has been requested.

• 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
• MDR Report Key: 11478077
• Report Number: 1119421-2021-00551
• Device Sequence Number: 4091919
• Product Code: HQL
• UDI-Device Identifier: 00380652332675
• UDI-Public: 00380652332675
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/12/2021

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: 09/20/2025
• Device Model Number: SA60WF
• Device Catalogue Number: SA60WF.205
• Device Lot Number: 15099301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/24/2021
• Initial Report FDA Received Date: 03/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1