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

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

Patient Problem Cataract (1766)

Event Type  Injury  

Event Description

Received a report from a doctor from the ascrs meeting in boston from april 5 - 8, 2024.The doctor reported 2 cases with implanted icl implantable lenses.The first case was icl complication referred with frozen anterior chamber corrected with icl removal and anterior chamber reconstruction with lenzoplastique based cataract removal and toric iol.The second case was icl + prk + cxl + intacs + cataract and 20/200 vision corrected by icl removal and staged lenzoplastique with toric iol to 20/20- vision.The reporter indicated both these icl cases were successfully corrected by the doctor.

Manufacturer Narrative

Claim#: (b)(4).

• Brand Name: QZIMPLANTABLE 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: 19217919
• MDR Text Key: 341457380
• Report Number: 2023826-2024-01996
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/05/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2024
• Initial Date FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: No
• 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
• Treatment: UNK.
• Patient Outcome(s): Required Intervention