MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. ACRYSOF IQ NATURAL SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number SN60WF

Device Problem Insufficient Information (3190)

Patient Problems Nausea (1970); Blurred Vision (2137); Visual Impairment (2138); Weight Changes (2607)

Event Date 05/31/2018

Event Type  Injury  

Manufacturer Narrative

A sample device was not returned for analysis; the lens remains implanted.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been no other complaints reported in the lot number.Additional information has been requested.(b)(4).

Event Description

A health professional reported that following an intraocular lens (iol) implant procedure, a patient experienced glare especially while eating, causing nausea and weight loss.The glare included shiny stripes and a strip in the outer half of the field of view.The glare subsided while lying down in a dark room with eyes closed and sunglasses.In a follow up, the physician reported after dilating the patient's pupil for ophthalmoscopy, the glare disappeared.The physician has planned weekly follow ups and daily talks with the patient.The patient has refrained from further intervention at this time.

Manufacturer Narrative

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

• Brand Name: ACRYSOF IQ NATURAL SINGLEPIECE IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: bryan blake ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7724854
• MDR Text Key: 115187722
• Report Number: 9612169-2018-00109
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/08/2018

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 Expiration Date: 08/31/2022
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.185
• Device Lot Number: 21201037
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/27/2018
• Initial Date FDA Received: 07/26/2018
• Supplement Dates Manufacturer Received: 09/12/2018
• Supplement Dates FDA Received: 10/08/2018
• Date Device Manufactured: 09/14/2017
• 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): Other