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

Model Number SA6AT3

Device Problem Malposition of Device (2616)

Patient Problem Blurred Vision (2137)

Event Date 06/11/2019

Event Type  Injury  

Manufacturer Narrative

The iol product history records were reviewed and documentation indicates the product met release criteria.Cartridge product history record could not be reviewed because facility did not provide a lot number or any identification traceable to the manufacturing documentation.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 one day following an intraocular lens (iol) implant procedure, the lens was noted to be rotated.The intended lens position was at 90 degrees and was verified visually and by a refractive analysis system following the uncomplicated primary procedure.At post op day one, the lens was noted to be rotated to 180 degrees, the cylinder power was doubled and the patient experienced blurry vision.A secondary procedure was performed to rotate the iol.One day following the rotation procedure, the iol was in place and the patient was pleased.

Manufacturer Narrative

The product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.The customer indicated the use a qualified cartridge.The customer indicated the use of a viscoelastic, which is not qualified for the lens/cartridge combination used.The product investigation could not identify a root cause.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
• MDR Report Key: 8768584
• MDR Text Key: 150299094
• Report Number: 1119421-2019-01071
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/12/2019

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 Expiration Date: 06/30/2022
• Device Model Number: SA6AT3
• Device Lot Number: 12551205
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/12/2019
• Initial Date FDA Received: 07/08/2019
• Supplement Dates Manufacturer Received: 08/19/2019
• Supplement Dates FDA Received: 09/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MONARCH C CARTRIDGE; ORA; PROVISC OVD; MONARCH C CARTRIDGE; ORA; PROVISC OVD
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR