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

Model Number	SA60AT
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint history and product history records were reviewed and the documentation indicated the product met release criteria.There were no other complaints reported in the lot number.The root cause has not been identified.Additional information was requested.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A customer reported that during an intraocular lens (iol) implant procedure, the lens was found to be defective.No patient harm was reported.Additional information has been requested.
Additional Manufacturer Narrative
The lens was returned for evaluation.Solution is dried on the lens.One haptic is broken in the gusset area (not returned).The optic is split\cracked on the edge towards the center of the lens.Product history records were reviewed and the documentation, indicated the product met release criteria.The reported lens damage was observed.All lenses are 100% inspected for cosmetic attributes.And the damage exhibited by the returned complaint sample would not have met companies release criteria.Based on our observation, it can be reasonably concluded, that the damage was 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.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: 11789414
• Report Number: 1119421-2021-00972
• Device Sequence Number: 19878937
• Product Code: HQL
• UDI-Device Identifier: 00380650141286
• UDI-Public: 00380650141286
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,Followup
• Report Date (Section B): 05/24/2021

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: 10/28/2025
• Device Model Number: SA60AT
• Device Catalogue Number: SA60AT.320
• Device Lot Number: 15110755
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2021
• Initial Date Received by Manufacturer: 04/14/2021
• Supplement Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 05/07/2021
• Supplement Report FDA Received Date: 05/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1