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

Model Number	SA60WF
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lens was returned positioned incorrectly in the lens case.Solution was dried on the lens.The lens was cleaned for further evaluation.The optic had scuff marks and cracks in the shape of an instrument used to grasp the lens was observed.A fold inspection was conducted using folding tweezers.The lens folded and unfolded with no abnormalities observed.A dimensional inspection was conducted.The lens met specifications.No cartridge was returned for evaluation.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Qualified associated products were indicated.The product investigation could not identify a root cause for the reported complaint.The lens was returned in the lens case and was not returned in a cartridge for evaluation.The qualified cartridge was not returned for evaluation.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 have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A facility representative reported that during intraocular lens (iol) implantation, the iol did not advance correctly.There was patient contact with the product.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: 12239804
• Report Number: 1119421-2021-01484
• Device Sequence Number: 11645594
• Product Code: HQL
• UDI-Device Identifier: 00380652332743
• UDI-Public: 00380652332743
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/28/2021

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: 12/23/2025
• Device Model Number: SA60WF
• Device Catalogue Number: SA60WF.240
• Device Lot Number: 15123369
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/07/2021
• Initial Report FDA Received Date: 07/28/2021
• 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: DUOVISC; MONARCH III IOL CARTRIDGE D