MAUDE Adverse Event Report: STAAR SURGICAL COMPANY VISIAN ICLS; LENS, INTRAOCULAR, PHAKIC

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Fatigue (1849); Headache (1880); Discomfort (2330)

Event Date 10/01/2017

Event Type  Injury  

Event Description

I got visian icls in 2017 and ever since then, i have had headaches, pulling of eye and face, bad interaction with head, tiredness.Fda safety report id# (b)(4).

• Brand Name: VISIAN ICLS
• Type of Device: LENS, INTRAOCULAR, PHAKIC
• Manufacturer (Section D): STAAR SURGICAL COMPANY
• MDR Report Key: 11506684
• MDR Text Key: 240678659
• Report Number: MW5100045
• Device Sequence Number: 2
• Product Code: MTA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/13/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/16/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 34 YR
• Patient Weight: 100