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

Model Number SN6AT3

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Adhesion(s) (1695); Blurred Vision (2137)

Event Date 10/23/2018

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.Product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A nurse reported that following a cataract extraction with intraocular lens (iol) implant procedure, the patient experienced blurred vision and iridocorneal adhesions were noted.The lens was explanted in a secondary procedure.Additional information was requested and received.

Manufacturer Narrative

Product evaluation: the lens was returned in the lens case.Viscoelastic is dried on the lens.The lens is pressed between two posts and into the well area.The optic has been cut in half typical of removal.The power and resolution could not be checked due to the optic damage.Product history records were reviewed and documentation indicates the product met release criteria.All indicated associated products are qualified.The root cause for the reported blurred vision and iridocorneal adhesion could not be determined.Due to the optic damage the power and resolution could not be checked.All lenses are 100% verified for focal length and cylinder power during manufacture.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: 8210709
• MDR Text Key: 131889829
• Report Number: 1119421-2019-00011
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 03/29/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: SN6AT3
• Device Catalogue Number: SN6AT3.235
• Device Lot Number: 12544413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Initial Date Manufacturer Received: 12/04/2018
• Initial Date FDA Received: 01/02/2019
• Supplement Dates Manufacturer Received: 03/04/2019
• Supplement Dates FDA Received: 03/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MONARCH C CARTRIDGE; MONARCH III IOL DELIVERY SYSTEM; PROVISC
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR