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

Model Number SA6AT7

Device Problem Malposition of Device (2616)

Patient Problem Visual Disturbances (2140)

Event Date 11/15/2022

Event Type  Injury  

Event Description

A facility representative reported that following a cataract extraction with intraocular lens (iol) implant procedure, the patient experienced iol surprise.The iol was exchanged in a secondary procedure for atiol (advanced technology intra ocular lens).Additional information has been requested and received stated that patient experienced visually symptomatic refractive error from malrotation of the toric iol.The iol was exchanged for the lens of a same company.There was no patient harm and the patient was not hospitalized.

Manufacturer Narrative

A sample device was 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.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Additional information provided in h.3., h.6.And h.10.The lens was returned for evaluation.Solution is dried on the lens.The lens is split across the center of the lens.Deep scratches and gouge marks are observed on the optic.A large piece of lens material is broken off the edge of the optic and not returned.A power and resolution inspection could not be conducted due to extensive damage.Lens damage was observed.The power and resolution of each lens is 100% evaluated during the manufacturing process to determine acceptability per model and diopter.The 19.5 diopter lens was replaced with a 18.5 diopter lens.Due to the exchange of a different toric and diopter lens, this may suggest that the replacement lens model was an improved choice for the patient's vision needs.The manufacturer internal reference number is: (b)(4).

• 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: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 16013267
• MDR Text Key: 305782970
• Report Number: 1119421-2022-02702
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SA6AT7
• Device Lot Number: 15101767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2022
• Date Manufacturer Received: 12/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female