MAUDE Adverse Event Report: STAAR SURGICAL COMPANY VISIAN IMPLANTABLE COLLAMER LENS (ICL); INTRAOCULAR LENS

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

Event Date 11/15/2023

Event Type  Injury  

Event Description

In 2008, i had visian staar implantable collamer lenses surgically placed in both eyes to correct my vision.In mid (b)(6) 2023, i started noticing a serious change in my vision, and in (b)(6) 2024, i was diagnosed with cataracts in both eyes.I now need to have the artificial lenses removed in addition to cataract treatment (at age 38).Reference report: mw5151903.

• Brand Name: VISIAN IMPLANTABLE COLLAMER LENS (ICL)
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY
• MDR Report Key: 18777377
• MDR Text Key: 336336169
• Report Number: MW5151902
• Device Sequence Number: 1
• Product Code: HQL
• 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: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability; Hospitalization
• Patient Sex: Male
• Patient Weight: 93 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White