MAUDE Adverse Event Report: STAAR SURGICAL COMPANY VISIAN ICL; LENS, INTAOCULAR, PHAKIC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cataract (1766); Visual Impairment (2138)

Event Date 04/23/2019

Event Type  Injury  

Event Description

Had visian icl procedure performed by (b)(6) in early 2017.Have since developed significant cataracts which require an iop procedure to correct.Currently experiencing loss of contrast in bright light, impaired depth perception, reduced field of vision, and reduced night vision.After full exam, surgeon is quoting additional (b)(6) out of pocket to perform iol procedure to correct outcome of icl procedure.Fda safety report id # (b)(4).

• Brand Name: VISIAN ICL
• Type of Device: LENS, INTAOCULAR, PHAKIC
• Manufacturer (Section D): STAAR SURGICAL COMPANY
• MDR Report Key: 8555318
• MDR Text Key: 143527405
• Report Number: MW5086195
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• 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: 04/23/2019

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?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/25/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 38 YR
• Patient Weight: 77