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

Model Number SN60WF

Device Problem Insufficient Information (3190)

Patient Problems Dry Eye(s) (1814); Foreign Body Sensation in Eye (1869); Scarring (2061); Increased Sensitivity (2065); Visual Impairment (2138); Halo (2227)

Event Date 12/12/2017

Event Type  Injury  

Manufacturer Narrative

A sample 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 are no other complaints in the lot.Additional information was requested and received.The manufacturer internal reference number is: (b)(4).

Event Description

A consumer reported that approximately 4 months after an intraocular lens (iol) implant procedure, he is still noticing issues that have been ongoing since day one after surgery.He reported "rims" in upper and side vision, flashes of colored light in side vision when driving at night, a floater that looks like a blob of vaseline, light sensitivity, and dry eye that has been treated with prescription eye drops.Early on, after surgery, an optometrist reported that there were corneal scars noted on the consumer's eye.The optometrist indicated that the consumer has been seen multiple times reporting foreign body sensations, dry eyes, and the feeling of "looking through binoculars." at his last appointment, the surgeon suggested that the consumer continue to use his dry eye treatment drops, omega 3 and also instructed that he do lid scrubs and war compresses.She also reported that the consumer had some posterior capsular opacities, in which the surgeon suggested a yag laser treatment, but the consumer declined.At the consumer's recent appointment, the optometrist noted that the cornea's were clear and no evidence of foreign body was found.

• Brand Name: ACRYSOF IQ NATURAL SINGLEPIECE IOL
• Type of Device: INTRAOCULAR LENS
• 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: 7512960
• MDR Text Key: 108227718
• Report Number: 1119421-2018-00594
• 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: consumer,health professional
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/14/2018

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: 12/31/2021
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.205
• Device Lot Number: 12518141
• Other Device ID Number: 00380655093207
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/18/2018
• Initial Date FDA Received: 05/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2017
• 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): Required Intervention
• Patient Age: 58 YR