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

Model Number ASKU

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Corneal Edema (1791); Corneal Scar (1793); Foreign Body Sensation in Eye (1869); Headache (1880); Red Eye(s) (2038); Blurred Vision (2137); Halo (2227); Eye Pain (4467); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/02/2020

Event Type  Injury  

Event Description

An assistant director reported that a blue tint with the wrong lens implanted.Patient had a blue tint with the wrong iol implanted.I had a second surgery to correct the 1st mistake the wrong implanted are causing.The blue tint was added after the second surgery.I have or had severe corneal swelling, blurring of vision with piercing pains shooting through at random times and eye become dark red and turned fire.Disable from health issues.Additional information has been requested.There are two medical device reports associated with this event.This is one of two.

Manufacturer Narrative

A sample device was not returned for analysis.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The product was not returned for analysis.The complaint history and product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation.The product investigation could not identify a root cause for the reported complaint.The product was not returned to evaluate.Follow up attempts were made.No further information has been provided.Not enough information was provided from the account for further investigation.Investigation has been completed based on current information.Based on our current tracking, there are no adverse trends for this reported complaint.No further action warranted at this time.The manufacturer internal reference number is: (b)(4).

Event Description

Additional information has been received from the medwatch form and reported that, patient read where can never events could be longer.The patient stated that wrong iol cataract lens implanted in the left eye for 43 days.The patient would like to send some of the last mediate notes.The mediator has reminded that the statue of limitations is the 29th pressure for forty three days- (43 days).She had a foreign object implanted in my left eye and she could not see two feet in distance.Her eye was completely covered in blood.Piercing pain in left eye.Bloodshot eye for over 21/2 months.Blindness and still now blurred vision.She told that her grandkids and others say at times her eye looks like a dead fish.At any time my lt.Eye looks as if someone has given me a black eye.At night it glows.She cannot read without having a bad headache afterwards, only radiating from her left eye.The blurring gets so bad it throws my balance off.Every hour of the day she had piercing pains shooting through the eye.She have developed more of a fear to even try to drive in the daytime, not knowing when her eye may blur and not return.If it's looking like a dead fisheye and a black eye it prevents her from going to family or friends¿ events.It feels as if something leaks out of her eye.The patient thought it was an injection at the surgery site, at times completely blurred vision.Being embarrassed every time a stranger asks patient, what's wrong with her eye or why is one blue and one brown.It was observed three weeks later, she got the doctor to look closer and doctor removed another stitch, that should have been removed three days after surgery.She had severe scarring and was never told anything from your doctor's, but she had cornea swelling.Another doctor stated severe scarring.The patient stated that would need cornea scarring removed or the cornea transplant.There are two medical device reports associated with this event.This is one of two.

Manufacturer Narrative

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

• Brand Name: ACRYSOF RESTOR 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: 14746869
• MDR Text Key: 294489633
• Report Number: 1119421-2022-01321
• Device Sequence Number: 1
• Product Code: MJP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ASKU
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ACRYSOF RESTOR TORIC.
• Patient Outcome(s): Required Intervention; Other
• Patient Sex: Female