MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - HUNTINGTON ACRYSOF TORIC ASPHERIC UV ABSORBING SINGLEPIECE IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number SA6AT3

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Visual Impairment (2138)

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.The product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.There have been no other complaints reported in the lot number.(b)(4).

Event Description

A physician reported that 2-3 days following an intraocular lens (iol) implant procedure, a patient has experienced shimmering light in the periphery of her vision.The iol was exchanged for a different lens model 2 weeks following the initial implant procedure due to the patient being very distraught over having to cover her right eye at all times due to a shimmering light in the periphery of her vision in all lighting and it would also pulsate.The patient informed the physician that the symptoms would only improve if she did not move from one position.Additional information was provided by the physician indicating that the patient's symptoms have completely resolved.The physician identified the photic phenomenon as positive dysphotopsia.

• Brand Name: ACRYSOF TORIC ASPHERIC UV ABSORBING SINGLEPIECE IOL
• Type of Device: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): ALCON RESEARCH, LTD. - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LTD. - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: cindy milam ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152231
• MDR Report Key: 8363101
• MDR Text Key: 136909004
• Report Number: 1119421-2019-00206
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/22/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: SA6AT3
• Device Lot Number: 12566018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/28/2019
• Initial Date FDA Received: 02/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention