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	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/02/2021
Type of Reportable Event	Serious Injury
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.There are two medical device reports associated with this patient.This report is associated with the right eye.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician has reported that one year following a cataract extraction with intraocular lens (iol) implant procedure, the posterior capsule became opacified and a yag capsulotomy was performed in 2017, the patient had a vitrectomy and epiretinal membrane peeling.The recent testing confirmed an optimal retinal profile.Thirteen years after the initial procedure a physician noted initial opacification of the iol.No further information is available.There are two files associated for this report.This complaint is for the right eye.
Additional Manufacturer Narrative
Additional information provided in h.10.Associated product information was not provided.It is unknown if a qualified combination of products were used.According to the file, the lens remains implanted; therefore, an evaluation of the product cannot be conducted.A review of the device history records indicate that the product met all manufacturing release criteria prior to final release from the manufacturing facility.An email summary sent to the lawyer was attached to the file.The information provided in that summary suggests potential external factors for the complaint.An excerpt from that email summary indicates that the patient suffered a complex clinical history, independently from lenses.The patient¿s medical report discloses a series of previous pathologies and a series of subsequent events that may have influenced the opacification of the lenses: (i) a corneal transplant at a young age, (ii) a serious car accident resulting in a detachment of the cornea and (iii) the vitrectomy.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: 12925622
• Report Number: 1119421-2021-02305
• Device Sequence Number: 4957842
• Product Code: HQL
• UDI-Device Identifier: 00380652555524
• UDI-Public: 00380652555524
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2012
• Device Model Number: SA60AT
• Device Catalogue Number: SA60AT.060
• Device Lot Number: 10752698
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2021
• Supplement Date Received by Manufacturer: 01/22/2022
• Initial Report FDA Received Date: 12/03/2021
• Supplement Report FDA Received Date: 02/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2007
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown