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

Model Number	SA60WF
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/24/2021
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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A facility representative reported that during an intraocular lens (iol) implant procedure a crack in the center of the implanted lens observed.Lens was removed on the same day and procedure was completed with another lens.Additional information has been requested; however, further information has not been received.
Additional Manufacturer Narrative
The lens was returned positioned incorrectly in the lens case.Blood and solution was dried on the lens.Both haptics are bent in the gusset and distal area.The optic was cut, typical of insertion and removal.Both cut optic portions had multiple small cracks observed.Associated products were not provided.It is unknown if qualified products were used.Upon return, the lens was observed to be placed into the lens case incorrectly resulting in damage.The reported lens damage was observed.Other lens damage was observed that may have occurred due to how the lens was positioned in the lens case for return.All lenses are 100% inspected for cosmetic attributes and the damage exhibited by the returned complaint sample 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.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: 12506130
• Report Number: 1119421-2021-01791
• Device Sequence Number: 5169594
• Product Code: HQL
• UDI-Device Identifier: 00380652332644
• UDI-Public: 00380652332644
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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,Followup
• Report Date (Section B): 01/03/2022

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: 04/13/2026
• Device Model Number: SA60WF
• Device Catalogue Number: SA60WF.190
• Device Lot Number: 15185960
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/31/2021
• Supplement Date Received by Manufacturer: 12/14/2021
• Initial Report FDA Received Date: 09/21/2021
• Supplement Report FDA Received Date: 01/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2021
• 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
• Patient Sex: Unknown