MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON IOL, UNSPECIFIED

Model Number ASKU

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Vitreous Floaters (1866); Blurred Vision (2137)

Event Type  Injury  

Manufacturer Narrative

A sample device was not returned for analysis; lens remained implanted in eye.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 consumer reported that, following intraocular lens (iol) implant procedure, the consumer was unable to see anything up close.Have film on the new lens and will be undergoing lazer surgery.Possible retinal specialist to remove fiber clusters in fluid in eye.There are two medical device reports associated with this patient.This report is for right eye.Additional information could not be obtained as the reporter is unwilling to follow-up.

Event Description

Additional information was received that, patient had the laser surgery to clear new lenses.Some clarity but vitreous fiber floaters are still there.

Manufacturer Narrative

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

• Brand Name: IOL, UNSPECIFIED
• Type of Device: UNK
• 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: 14388751
• MDR Text Key: 291596011
• Report Number: 1119421-2022-01014
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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
• Initial Date Manufacturer Received: 04/18/2022
• Initial Date FDA Received: 05/13/2022
• Supplement Dates Manufacturer Received: 06/03/2022
• Supplement Dates FDA Received: 06/29/2022
• 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
• Patient Outcome(s): Other; Required Intervention