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

Model Number SN6AT7

Device Problem Overcorrection (3006)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/13/2019

Event Type  Injury  

Manufacturer Narrative

The lens was returned adhered to the inside of a small, solution dispensing-type container.A product identification label was placed on the container.The lens was removed for evaluation.Solution was dried on the lens.No damage was apparent.The lens was cleaned with lphse for further assessment.No damage was observed to the lens.The power and resolution was assessed by engineering tech.The optical resolution is acceptable; lens meets specification readings for the lens model focal length 20.5 and cylinder 4.50.Product history records were reviewed and the documentation indicated the product met release criteria.The customer indicated the use of a qualified cartridge with a non-qualified handpiece.Cartridge product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation.Viscoelastic was not provided.It is unknown if the qualified product was used.The product investigation could not identify a root cause.The manufacturer internal reference number is: (b)(4).

Event Description

A doctor reported that following a cataract extraction with intraocular lens (iol) implant procedure, an overcorrection of astigmatism was noted.The lens was exchanged in a secondary procedure for a different model.Additional information was requested.

Event Description

Additional information was provided by the surgeon that postoperatively the patient visited the hospital of origin for a follow up, however, the vision was out of focus, so that the patient visited another hospital one month following the procedure.Since corneal irregular astigmatism was considered, after discussion with the patient, the iol was replaced with a different model iol.Postoperatively, no issues with subjective or objective symptom were noted.Error on targeted power is noted as the patient problem.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ TORIC SINGLEPIECE IOL
• Type of Device: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 8545519
• MDR Text Key: 142942741
• Report Number: 1119421-2019-00524
• Device Sequence Number: 1
• Product Code: MJP
• Combination Product (y/n): N
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 06/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: SN6AT7
• Device Catalogue Number: SN6AT7A205
• Device Lot Number: 12644086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2019
• Date Manufacturer Received: 05/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AE-9036SP; MONARCH III D CARTRIDGE; AE-9036SP; MONARCH III D CARTRIDGE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR