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

Model Number ASKU

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Foreign Body Sensation in Eye (1869)

Event Date 04/11/2018

Event Type  Injury  

Manufacturer Narrative

Product evaluation: the product was not returned for analysis.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.Additional information has been requested.(b)(4).

Event Description

A representative with a cataract support program reported a consumer that is having issues with her lens six months following an intraocular lens (iol) implant procedure.She is experiencing redness and foreign body sensation.She was told by a physician that her eye is healing fine from the surgery, however, she is currently using topical medication in her eye.The consumer did state that she noticed the redness is better, but she still feels like something in her eye like an eyelash.The lens remains implanted.

Manufacturer Narrative

Product evaluation: the product investigation could not identify a root cause for the reported complaint.Not enough information was provided from the account for further investigation.It was provided that the customer stated that their ecp said the eye was healing fine from surgery.Customer stated drops are being taken, and that they noticed the redness is better, though the sensation of something in the eye remains.(b)(4).

• Brand Name: IOL, UNSPECIFIED
• Type of Device: UNK
• Manufacturer (Section D): ALCON RESEARCH, LTD. - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LTD. - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: bryan blake ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7480046
• MDR Text Key: 107127795
• Report Number: 1119421-2018-00507
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/17/2018

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 Model Number: ASKU
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/11/2018
• Initial Date FDA Received: 05/02/2018
• Supplement Dates Manufacturer Received: 06/22/2018
• Supplement Dates FDA Received: 07/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention