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

Model Number SN60WF

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problems Adhesion(s) (1695); Blurred Vision (2137); Visual Disturbances (2140); Blood Loss (2597)

Event Date 11/12/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A facility representative reported that during an intraocular lens (iol) implant procedure, the patient experienced slight bleeding on the iris and the surgery was completed by slightly increasing the intraocular pressure to be on the safe side.The patient rested in the supine position for three hours in the hospital.The patient was seen the following day and a lot of red blood cells were found on the iol surface causing the patient to have blurry vision and haze.The patient was seen in follow up for one week but haze remained in the front and center of the iol.A secondary procedure was performed, viscoelastic was injected in the eye to spread the red blood cells.The anterior chamber and iol were cleaned and remains implanted in the eye.The haze has resolved.It was also noted that adhesion of the iol maybe the cause of the issue and the surface of iol is sticky which makes it easy for the red blood cells to adhere to the surface.

Manufacturer Narrative

The product was not returned.Product history records were reviewed and documentation indicated the product met release criteria.The root cause for the reported events does not appear to be related to the lens.The lens remains implanted.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ NATURAL SINGLEPIECE IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 10927738
• MDR Text Key: 218944507
• Report Number: 1119421-2020-01812
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WFA250
• Device Lot Number: 15006277
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MONARCH III C CARTRIDGE; MONARCH III IOL DELIVERY SYS; PROVISC; MONARCH III C CARTRIDGE; MONARCH III IOL DELIVERY SYS; PROVISC
• Patient Outcome(s): Other
• Patient Age: 78 YR