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

Catalog Number N/A

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

Patient Problems Uveitis (2122); Visual Disturbances (2140)

Event Type  Injury  

Manufacturer Narrative

Claim#: (b)(4).

Event Description

An article published in clinical ophthalmology on 9 january 2024 titled, "a comprehensive retrospective analysis of evo/evo+ implantable collamer lens: evaluating refractive outcomes in the largest single center study of icl patients in the united states" considers the retrospective outcomes of 225 eyes undergoing evo/evo+ implantation from (b)(6) 2022.Out of 225 eyes, 8 eyes required enhancement by either cornea-based refractive surgery or toric icl rotation.4 eyes underwent lasik enhancement.One eye underwent prk enhancement.3 eyes underwent icl rotation.2 eyes underwent icl explant due to persistent bilateral idiopathic anterior uveitis.The authors conclude that the largest us single-center analysis of evo/evo+ icl implantation demonstrates strong early results and infrequent adverse events, supporting icl safety and effectiveness.High predictability and favorable visual outcomes, including 20/20 or better, highlight the reliability of this technology.

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Type of Device: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 18646321
• MDR Text Key: 334620204
• Report Number: 2023826-2024-00409
• 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: Manufacturer
• Source Type: Study,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/08/2024

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: Health Professional
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/05/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention