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

Model Number VTICM5 13.7

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

Patient Problems Intraocular Pressure Increased (1937); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/10/2024

Event Type  Injury  

Event Description

The reporter indicated that a 13.7mm vticm5 13.7 implantable collamer lens of -13.50/2.0/076 (sphere/cylinder/axis) was implanted into the patients left eye (os) on (b)(6) 2024.Angle closure with elevated iop was reported.On (b)(6) 2024 the lens was explanted.A replacement lens of a shorter length and different power was implanted into the patient's eye at a later date and the problem was resolved.The cause was reported as device.

Manufacturer Narrative

H6 clinical code:4581 angle closure with elevated iop.H6-investigation type 4110: lens work order search- no similar complaint event(s) within associated lots were found.Claim# (b)(4).

• 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 SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 18897371
• MDR Text Key: 337589003
• Report Number: 2023826-2024-01109
• Device Sequence Number: 1
• Product Code: QCB
• UDI-Device Identifier: 00841542118699
• UDI-Public: 00841542118699
• 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: 02/15/2024

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: VTICM5 13.7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2024
• Initial Date FDA Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/22/2022
• 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: CARTRIDGE SFC-45 LOT# 1719892; FOAM TIP PLUNGER (FTP), LOT# 1654366; INJECTOR MODEL: MSI-PF, LOT# 1654373
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR
• Patient Sex: Female