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

Model Number	SA60AT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Disturbances (2140); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for analysis.Complaint history and product history records could not be reviewed because the report did not provide a lot number or any identification traceable to the manufacturing documentation.The file has been opened from a literature report "persistent negative dysphotopsia and small eyes.Per the report the patient exhibited classical bilateral negative dysphotopsia.Negative dysphotopsia has been associated with high-powered iols, small pupils and positive angle k, noted or likely seen in this highly myopic patient.The exact etiology remains elusive because of its multifactorial origins and inconsistent occurrence.A nasal capsulotomy was performed.The patient was markedly improved in the left eye and able to return to his life without visual disturbances.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
In a journal article, the physician reported that following an intraocular lens (iol) implant procedure patient experienced consistent with negative dysphotopsia (nd) in the form of temporal dark arcs.Slit lamp examination revealed trace meibomian gland disease.The posterior capsule was intact with trace posterior capsule opacification.Nasal capsulectomy was performed as intervention.Additional information not requested due to lack of reporter contact information.

• 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: 13003630
• Report Number: 1119421-2021-02377
• Device Sequence Number: 11924142
• Product Code: HQL
• UDI-Device Identifier: 00380650049032
• UDI-Public: 00380650049032
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 12/14/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: SA60AT
• Device Catalogue Number: SA60AT.360
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2021
• Initial Report FDA Received Date: 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 56 YR
• Patient Sex: Male