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

Model Number SN6AT9

Device Problems Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191)

Patient Problems Blurred Vision (2137); Visual Impairment (2138)

Event Date 08/18/2021

Event Type  Injury  

Event Description

A non healthcare professional reported that following implantation of an intraocular lens (iol) the lens was dislocated due to peripheral capsulotomy.The patient experienced double vision.The lens was explanted in a secondary procedure.Additional information was requested.

Manufacturer Narrative

A sample device was not 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

The lens was returned wrapped in gauze inside a small brown envelope labeled miller.The lens was adhered to a small piece of paper with viscoelastic.The lens was cleaned with klrp.The lens was damaged on the edge.Power and resolution were verified.The optical resolution was acceptable; lens met specification readings for an company lens focal length 25.0 and cylinder 6.00.The root cause for the reported visual issues could not be determined.No problem was found with the returned lens.Each lens is subjected to a 100% assessment of the power (spherical and cylinder) and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.Information was provided that the toric lens (6.00cyl), 25.0 diopter lens was exchanged for a non-toric 21.0 diopter lens.The difference of 6.00 cylinder power would indicate a calculation issue may have occurred.The manufacturer internal reference number is: (b)(4).

Event Description

Additional information was requested and received stating the patient experienced blurred visual acuity.

• 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 ; 8007579780
• MDR Report Key: 14209524
• MDR Text Key: 290081450
• Report Number: 1119421-2022-00858
• Device Sequence Number: 1
• Product Code: MJP
• UDI-Device Identifier: 00380652279192
• UDI-Public: 00380652279192
• 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: 05/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SN6AT9
• Device Catalogue Number: SN6AT9.250
• Device Lot Number: 15117954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 04/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MONARCH III IOL CARTRIDGE D.; MONARCH III IOL INJECTOR.; PROVISC.
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male