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

Model Number SN6AT8

Device Problem Material Opacification (1426)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

A sample device was not returned for analysis.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).

Event Description

A physician reported that following intraocular lens (iol) implantation, the lens was opacified.The iol was explanted and exchanged for same model with different diopter.Additional information has been requested; however, further information has not been received.

Manufacturer Narrative

The lens was returned in a non-company lens case.Solution was dried on the lens.The optic was torn/split/cracked and cut with multiple scratches and scrape marks on the anterior and posterior sides of the lens.The observed damage is typical of insertion and removal.Power and resolution testing could not be conducted due to the extensive optic damage.Associated products were not provided.It is unknown if a qualified products were used.The product investigation could not identify a root cause for the reported complaint.Other then the lens damage the lens appears clear.The power and resolution of each lens is 100% evaluated during the manufacturing process to determine acceptability per model and diopter.Information was provided that the company lens (5.25cyl), 12.5 diopter lens implanted in 2012 was exchanged for a company lens (4.50cyl), 7.0 diopter lens.The company lens (5.25cyl), 12.5 diopter lens being exchanged in 2021 (nine years later) for a company lens (4.50cyl), 7.0 diopter lens may suggest that the replacement lens model was an improved choice for the patient's current vision needs.

• 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
• 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 ; 8175514979
• MDR Report Key: 12487400
• MDR Text Key: 271870925
• Report Number: 1119421-2021-01772
• Device Sequence Number: 1
• Product Code: MJP
• UDI-Device Identifier: 00380652277365
• UDI-Public: 00380652277365
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2016
• Device Model Number: SN6AT8
• Device Catalogue Number: SN6AT8.125
• Device Lot Number: 12025817
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/23/2021
• Initial Date FDA Received: 09/17/2021
• Supplement Dates Manufacturer Received: 11/16/2021
• Supplement Dates FDA Received: 12/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2011
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female