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

Model Number SA6AT3

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Failure of Implant (1924); Visual Impairment (2138)

Event Date 02/26/2019

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.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.The manufacturer internal reference number is: (b)(4).

Event Description

A surgeon reported that following an intraocular lens (iol) implant procedure, the patient has residual astigmatism and vertical double vision.The surgeon sees nothing else on examination of anterior segment or retina.Additional information provided by the surgeon that the vertical diplopia has been present since day 1 post-op and still there when fully corrected.Topography was normal pre-op and no change post-op, and retina looks good by oct and no edema.The iol looks good with no apparent defects or scratches.There are 3 small horizontal capsule folds but the surgeon does not think the event is due to this based on his experience and patient doesn¿t report streaks of light.Further information provided by the surgeon that all measurements were checked.Residual cylinder could be measurements as the new scan suggests a different toricity, but does not explain diplopia.Thinking lens optic issue.Additional information provided by the surgeon that the iol has been exchanged for a different model iol with different toric power.The diplopia is gone.Patient is thrilled.

• Brand Name: ACRYSOF TORIC ASPHERIC UV ABSORBING SINGLEPIECE IOL
• Type of Device: LENS, INTRAOCULAR, TORIC OPTICS
• 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: cindy milam ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152231
• MDR Report Key: 8741116
• MDR Text Key: 149411289
• Report Number: 1119421-2019-01042
• 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: 06/27/2019

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: 07/31/2022
• Device Model Number: SA6AT3
• Device Lot Number: 12563261
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/05/2019
• Initial Date FDA Received: 06/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2017
• 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
• Treatment: AMVISC
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR