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

Model Number	SA60AT
Medical Device Problem Code	Material Opacification (1426)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 physician reported that following implantation of the implant (iol), the lens was whitening.Additional information was requested.
Additional Manufacturer Narrative
Evaluation of attached photos was provided by global quality technical and customer affairs: pseudophakic one slit lamp photo is available and reviewed.It is grainy in appearance with low resolution.The lighting used is direct lighting and the image appears to be focused at the level of the cornea and anterior chamber.A green coloration (presumably nafl dye) is seen in the top half of the cornea from approximately 11 o¿clock to 3 o¿clock which further blurs underlying details.In the inferior portion of the visible cornea the remaining anterior capsule is visible with expected opacification.The iol is difficult to visualize but appears ¿whitish¿.It is not possible to provide a more definitive description of the photo or determine the impact of light reflection on the clarity of the iol due to the quality of the image.The product investigation could not identify a root cause for the reported complaint.The clinical impact of the described photo observations cannot be determined from a photo assessment.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
• 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: 12685368
• Report Number: 1119421-2021-01964
• Device Sequence Number: 17137093
• Product Code: HQL
• UDI-Device Identifier: 00380652555777
• UDI-Public: 00380652555777
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2022

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: 06/30/2016
• Device Model Number: SA60AT
• Device Catalogue Number: SA60AT.185
• Device Lot Number: 12065574
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/05/2021
• Supplement Date Received by Manufacturer: 12/17/2021
• Initial Report FDA Received Date: 10/22/2021
• Supplement Report FDA Received Date: 01/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2011
• 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: Male