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

Model Number VICMO 13.7

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

Patient Problems Corneal Edema (1791); Intraocular Pressure Increased (1937)

Event Date 03/15/2023

Event Type  Injury  

Manufacturer Narrative

H6 - type of investigation - lens work order search: no similar complaint type events reported for units within the same lot.Claim #: (b)(4).

Event Description

The reporter indicated that a 13.7mm, vicmo 13.7, -14.50 diopter, implantable collamer lens was implanted into the patients right eye (od) on (b)(6) 2023.On (b)(6) 2023 the lens was explanted due to elevated intraocular pressure without pupil block and angle closure.A replacement lens of shorter length was later implanted and the problem resolved.It was also reported that corneal edema was noticed on (b)(6) 2023, however it did not require treatment beyond was is standard after ocular surgery and the corneal edema resolved.In the reporters opinion the cause of the event was the device.

• 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 SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene enriquez ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 16850587
• MDR Text Key: 314355541
• Report Number: 2023826-2023-01613
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/04/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: VICMO 13.7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2023
• Initial Date FDA Received: 05/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2022
• 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: INJECTOR MODEL: MSI-TF, LOT# 1589898.
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR