MAUDE Adverse Event Report: STAAR SURGICAL STAAR; ICL

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

Patient Problem Impaired Healing (2378)

Event Date 03/10/2014

Event Type  No Answer Provided  

Event Description

Staar icl implanted ou by another surgeon in 2007, lasik enhancement 2007, (b)(6) 2014 - vcc 20/25+1 25 clear k with laser flap ou reduced at site.Od - no image on spec.Endothelial cell ct - os - 2398.Slit - catheter ou.Icl touch to lens and posterior iris.Fundus - nl.Topography showed poor lasik ectasia os - od nl post lasik.Icl removed in combination with phaco iol (b)(6) 2014.Diagnosis or reason for use: high myopia.

• Brand Name: STAAR
• Type of Device: ICL
• Manufacturer (Section D): STAAR SURGICAL
• MDR Report Key: 3851386
• MDR Text Key: 17156812
• Report Number: MW5036453
• Device Sequence Number: 1
• Product Code: MTA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/15/2014

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: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/30/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR