MAUDE Adverse Event Report: STAAR SURGICAL COMPANY EVO ICL (IMPLANTABLE COLLAMER LENS), RIGHT EYE; LENS, INTRAOCULAR, PHAKIC

Device Problem Product Quality Problem (1506)

Patient Problem Loss of Vision (2139)

Event Date 02/28/2023

Event Type  Injury  

Event Description

Had staar medical's implantable collamer lens, evo icl implanted into both right and left eye.Noticed next day a loss of peripheral vision.Returned to doctor, was told to wait a week.Returned to have retina checked, retina was okay.Today, (b)(6), issue still present.Attempted to contact company (b)(6), was refused information.This side effect was not listed as possible side effect.I am now told the lens, even when advertised as removable, is indeed not removable, so side effects are not reversible.I would have never had this procedure done if i knew this was a possible side effect.Reference report: mw5116465.

• Brand Name: EVO ICL (IMPLANTABLE COLLAMER LENS), RIGHT EYE
• Type of Device: LENS, INTRAOCULAR, PHAKIC
• Manufacturer (Section D): STAAR SURGICAL COMPANY
• MDR Report Key: 16706808
• MDR Text Key: 313006483
• Report Number: MW5116464
• 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: 04/05/2023

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/07/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 31 YR
• Patient Sex: Male
• Patient Weight: 78 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White