MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. ACRYSOF SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number	SA60AT
Medical Device Problem Code	Material Opacification (1426)
Health Effect - Clinical Codes	Visual Impairment (2138); Visual Disturbances (2140); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.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 physician reported that following approximately 6 and a half years of an intraocular lens (iol) implant procedure, the physician noticed that the iol had become opaque when the patient came for follow-up.There was no impact on visual acuity of patient.
Additional Manufacturer Narrative
The product was not returned for analysis.Fourteen slit lamp images were submitted and reviewed.Five of the images show a full view of the dilated pupil beyond edge of the capsule, with an ¿opaque¿ appearing iol as reported.The other nine images show a cross sectional view that may be consistent with a dense confluence of microvacuoles within the iol that is sometimes referred to as sub-surface nano glistenings.Based on the content provided in the medical information review, microvacuoles/nano glistenings have been observed but the cause cannot be determined.A definitive determination of iol condition cannot be made without the evaluation of the physical product.A final root cause cannot be determined based on available information.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was requested and received from the initial reporter, who stated that the patient previously had good visual acuity after iol implantation.However, the patient now reports being unable to drive and experiencing other related difficulties.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received from the senior assistant editor stating the patient has diminished quality of vision.He cannot see if the light comes from the front side.The patient's left eye was already blind, and now he has compromised vision in the right eye too.The patient was quite depressed and frustrated with this event.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF SINGLEPIECE IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 16127808
• Report Number: 9612169-2023-00032
• Device Sequence Number: 3326968
• Product Code: HQL
• UDI-Device Identifier: 00380652555876
• UDI-Public: 00380652555876
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: SA60AT
• Device Catalogue Number: SA60AT.235
• Device Lot Number: 21136985
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2022
• Supplement Date Received by Manufacturer: 02/24/2023; 06/20/2023; 09/15/2023
• Initial Report FDA Received Date: 01/09/2023
• Supplement Report FDA Received Date: 03/23/2023; 07/19/2023; 10/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2015
• 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: Other
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 67 KG