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

Model Number SN6AT4

Device Problem Unintended Movement (3026)

Patient Problem Capsular Bag Tear (2639)

Event Date 09/20/2018

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.(b)(4).

Event Description

A physician reported that two weeks following a cataract extraction with intraocular lens (iol) implant procedure, the iol rotated.Visual acuity not affected.Approximately one month following the procedure, a posterior capsule rupture was observed, but the physician considers that it had no causal relationship with the product.No treatment has been given to the patient.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

Additional information was provided that the patient developed keratoconjunctivitis sicca following the procedure.The posterior capsule rupture was considered to be mild with no causal relationship to the device.The event is caused by the operation at the time of cataract surgery.The patient is unrecovered.Further information provided that the iol rotated 2 weeks following the procedure with no impact on 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
• MDR Report Key: 8084641
• MDR Text Key: 127580400
• Report Number: 1119421-2018-01619
• 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,Followup
• Report Date: 08/04/2019

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?: Yes
• Device Operator: Health Professional
• Device Model Number: SN6AT4
• Device Catalogue Number: SN6AT4A210
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/24/2018
• Initial Date FDA Received: 11/19/2018
• Supplement Dates Manufacturer Received: 01/10/2019; 07/10/2019
• Supplement Dates FDA Received: 02/06/2019; 08/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 73 YR