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

Model Number VTICMO12.6

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

Patient Problems Endophthalmitis (1835); Headache (1880); Hypopyon (1913); Blurred Vision (2137); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/12/2024

Event Type  Injury  

Manufacturer Narrative

The device remains implanted; therefore, a product evaluation cannot be performed.A review of the device labeling was completed.Hypopyon and endophthalmitis are identified in the labeling as known adverse events from icl implantation and are established risks associated with use of the device.The directions for use adequately provides instructions for icl implantation, which includes precautions, warnings and associated risks and adverse events.Dfu statements include: there may be a need for other types of secondary surgical intervention to treat some adverse events.There may be a loss of best spectacle corrected visual acuity.As with implantation of other types of intraocular lenses, potential adverse events can include, but are not limited to infection (endophthalmitis) and hypopyon.An adverse event appears to have occurred but does not appear to have been a problem with the device.Health impact- clinical code: 4581 - fibrin, reduced visual acuity.Health impact - additional surgery: (b)(6).Health effect impact code - additional medications: (b)(6) work order search: no similar complaint was reported for units within the same lot.Claim # (b)(4).

Event Description

The reporter indicated the surgeon implanted a 12.6mm vticmo implantable collamer lens, -16.50/+1.50/061 (sphere/cylinder/axis), into the patient's left eye (os) on (b)(6) 2024.The surgeon reported presentation of hypopyon suspecting endophthalmitis.The patient experienced blurred vision and headaches.On day two post-op, the patient presented with fibrin and reduced visual acuity.Management included antibiotic injection, increased steroid drop therapy and ac washout.Gram stain and cultures were negative for organisms.On 31-jan-2024, patient visual acuity is reported as 20/25.The surgeon suspects cause of the event may be associated with the patient's recent sinus infection.The lens remains implanted.

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Type of Device: PHAKIC TORIC 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: 18669620
• MDR Text Key: 334913752
• Report Number: 2023826-2024-00272
• Device Sequence Number: 1
• Product Code: QCB
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/13/2024

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 Model Number: VTICMO12.6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/13/2024
• Initial Date FDA Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/20/2023
• 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